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Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab

Primary Purpose

Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Patient Observation
Biopsy
Biospecimen Collection
Questionnaire Administration
Quality-of-Life Assessment
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anatomic Stage I Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age >= 18 years Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 Triple Negative Breast Cancer: Patients with a history of stage T1cN1-2 or T2-4N0-2 breast cancer according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator in radiologic assessment, clinical assessment or both Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Isolated tumor cells are considered node-negative Estrogen (ER) and progesterone (PR) =< 10%; HER2-negative by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (immunohistochemistry [IHC] and fluorescence in situ hybridization [FISH]) If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy and ICI therapy should have been completed preoperatively An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization * Note: Adjuvant radiation can be given on study. If given, it is encouraged to be given concurrently with pembrolizumab, per investigator discretion. Treatment with adjuvant pembrolizumab is strongly discouraged prior to participation in this trial, but if administered (e.g., if patients are awaiting pathology results), pembrolizumab may be administered for up to 6 weeks post-surgery and must be completed prior to registration Use of investigational anti-cancer agents must be discontinued at time of registration Adequate excision: Surgical removal of all clinically evident disease in the breast and lymph nodes as follows: Breast surgery: Total mastectomy or breast-conserving surgery with histologically negative margins, including no ink on tumor for DCIS, at the time of excision ** For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of ductal carcinoma in-situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates DCIS at the line of resection, additional operative procedures may be performed to obtain clear margins. If DCIS is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection Lymph node surgery: For a patient with clinically N0 disease, a sentinel lymph node biopsy should have been performed at time of surgical evaluation, and if pathologically node positive, the patient is no longer eligible. Isolated tumor cells are considered node-negative For a patient with clinically N1 disease at diagnosis (with positive results from a fine-needle aspiration, core biopsy, or sentinel node biopsy performed prior to preoperative therapy) additional surgical evaluation of the axilla following preoperative therapy is required *** If they become cN0 (no palpable adenopathy), then a sentinel lymph node biopsy could have been performed at time of surgery (axillary dissection would also be permitted); if the sentinel lymph node biopsy is positive, the patient is no longer eligible If sentinel node biopsy performed before preoperative therapy was negative, no additional surgical evaluation of the axilla is required after preoperative therapy. If sentinel node biopsy performed before preoperative therapy was positive, an ALND is required after preoperative therapy If the only sentinel node identified by isotope scan is in the internal mammary chain, surgical evaluation of the axilla is still required If sentinel node evaluation after preoperative therapy is negative, no further additional surgical evaluation of the axilla is required Axillary dissection without sentinel node evaluation is permitted as the initial or sole axillary evaluation after preoperative therapy If breast-conserving surgery was performed but patient will not be receiving breast radiation, the patient is not eligible Not pregnant and not nursing, because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =< 7 days prior to randomization is required Absolute neutrophil count (ANC) >= 1,000/mm^3 Platelet Count >= 100,000/mm^3 Estimated glomerular filtration rate (eGFR) >= 15 mL/min/1.73m^2 Total Bilirubin =<1.5 x upper limit of normal (ULN) * Patients with Gilbert's disease with a total bilirubin =< 2.5 x ULN and direct bilirubin within normal limits are permitted Aspartate aminotransferase (AST) serum aspartate aminotransferase [SGOT] / alanine aminotransferase (ALT) serum glutamic pyruvic transaminase [SGPT] =< 3 x institutional ULN Patients must be willing to provide tumor tissue from the diagnostic core biopsy. If inadequate tumor tissue is available, patients are still eligible to participate in the trial Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial Exclusion Criteria: No stage IV (metastatic) breast cancer No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed No evidence of recurrent disease following preoperative therapy and surgery No known active liver disease, e.g. due to hepatitis B virus (HBV), hepatitis C virus (HCV), autoimmune hepatic disorders, or sclerosing cholangitis No history of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to pembrolizumab or murine proteins or any components of the product * Note: Prior immune-related adverse events (irAEs) are allowed if they resolved and the patient tolerated subsequent therapy without requiring chronic steroids for the irAE No medical conditions that require chronic systemic steroids (>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy Patients who are unable or unwilling to comply with the requirements of the protocol per investigator assessment are not eligible

Sites / Locations

  • Thomas HospitalRecruiting
  • Mobile Infirmary Medical CenterRecruiting
  • Kingman Regional Medical CenterRecruiting
  • Highlands Oncology Group - FayettevilleRecruiting
  • Highlands Oncology Group - RogersRecruiting
  • Highlands Oncology GroupRecruiting
  • PCR OncologyRecruiting
  • Kaiser Permanente DublinRecruiting
  • Kaiser Permanente-FremontRecruiting
  • Kaiser Permanente-FresnoRecruiting
  • Kaiser Permanente-ModestoRecruiting
  • Kaiser Permanente-OaklandRecruiting
  • Kaiser Permanente-RosevilleRecruiting
  • Kaiser Permanente Downtown CommonsRecruiting
  • Kaiser Permanente-South SacramentoRecruiting
  • Kaiser Permanente-San FranciscoRecruiting
  • Kaiser Permanente-Santa Teresa-San JoseRecruiting
  • Kaiser Permanente San LeandroRecruiting
  • Kaiser San Rafael-GallinasRecruiting
  • Kaiser Permanente Medical Center - Santa ClaraRecruiting
  • Saint John's Cancer InstituteRecruiting
  • Kaiser Permanente-Santa RosaRecruiting
  • Kaiser Permanente-South San FranciscoRecruiting
  • Kaiser Permanente-VallejoRecruiting
  • Kaiser Permanente-Walnut CreekRecruiting
  • Danbury HospitalRecruiting
  • Norwalk HospitalRecruiting
  • Beebe South Coastal Health CampusRecruiting
  • Helen F Graham Cancer CenterRecruiting
  • Medical Oncology Hematology Consultants PARecruiting
  • Beebe Health CampusRecruiting
  • MedStar Georgetown University HospitalRecruiting
  • MedStar Washington Hospital CenterRecruiting
  • Morton Plant HospitalRecruiting
  • Mease Countryside HospitalRecruiting
  • Saint Joseph's Hospital/Children's Hospital-TampaRecruiting
  • Phoebe Putney Memorial HospitalRecruiting
  • Kaiser Permanente Moanalua Medical CenterRecruiting
  • Illinois CancerCare-BloomingtonRecruiting
  • Illinois CancerCare-CantonRecruiting
  • Illinois CancerCare-CarthageRecruiting
  • Centralia Oncology ClinicRecruiting
  • Carle at The RiverfrontRecruiting
  • Cancer Care Specialists of Illinois - DecaturRecruiting
  • Decatur Memorial HospitalRecruiting
  • Illinois CancerCare-DixonRecruiting
  • Crossroads Cancer CenterRecruiting
  • Illinois CancerCare-EurekaRecruiting
  • Illinois CancerCare-GalesburgRecruiting
  • Illinois CancerCare-Kewanee ClinicRecruiting
  • Illinois CancerCare-MacombRecruiting
  • Carle Physician Group-Mattoon/CharlestonRecruiting
  • Illinois CancerCare-Ottawa ClinicRecruiting
  • Illinois CancerCare-PekinRecruiting
  • Illinois CancerCare-PeoriaRecruiting
  • Illinois CancerCare-PeruRecruiting
  • Illinois CancerCare-PrincetonRecruiting
  • Southern Illinois University School of MedicineRecruiting
  • Springfield ClinicRecruiting
  • Memorial Medical CenterRecruiting
  • Carle Cancer CenterRecruiting
  • Illinois CancerCare - WashingtonRecruiting
  • Mercy HospitalRecruiting
  • Oncology Associates at Mercy Medical CenterRecruiting
  • Jennie Edmundson Memorial HospitalRecruiting
  • Heartland Oncology and Hematology LLPRecruiting
  • Cancer Center of Kansas - ChanuteRecruiting
  • Cancer Center of Kansas - Dodge CityRecruiting
  • Cancer Center of Kansas - El DoradoRecruiting
  • Cancer Center of Kansas-IndependenceRecruiting
  • University of Kansas Cancer CenterRecruiting
  • Cancer Center of Kansas-KingmanRecruiting
  • Cancer Center of Kansas-LiberalRecruiting
  • Cancer Center of Kansas - NewtonRecruiting
  • Olathe Health Cancer CenterRecruiting
  • University of Kansas Cancer Center-Overland ParkRecruiting
  • University of Kansas Hospital-Indian Creek CampusRecruiting
  • Cancer Center of Kansas - ParsonsRecruiting
  • Cancer Center of Kansas - PrattRecruiting
  • Cancer Center of Kansas - SalinaRecruiting
  • Cancer Center of Kansas - WellingtonRecruiting
  • University of Kansas Hospital-Westwood Cancer CenterRecruiting
  • Cancer Center of Kansas-Wichita Medical Arts TowerRecruiting
  • Ascension Via Christi Hospitals WichitaRecruiting
  • Cancer Center of Kansas - WichitaRecruiting
  • Cancer Center of Kansas - WinfieldRecruiting
  • Ascension Providence Hospitals - NoviRecruiting
  • Ascension Providence Hospitals - SouthfieldRecruiting
  • Abbott-Northwestern HospitalRecruiting
  • Park Nicollet Clinic - Saint Louis ParkRecruiting
  • Saint Francis Medical CenterRecruiting
  • Parkland Health Center - FarmingtonRecruiting
  • Truman Medical CentersRecruiting
  • University of Kansas Cancer Center - NorthRecruiting
  • University of Kansas Cancer Center - Lee's SummitRecruiting
  • University of Kansas Cancer Center at North Kansas City HospitalRecruiting
  • Washington University School of MedicineRecruiting
  • Missouri Baptist Medical CenterRecruiting
  • Sainte Genevieve County Memorial HospitalRecruiting
  • Mercy Hospital SpringfieldRecruiting
  • Missouri Baptist Sullivan HospitalRecruiting
  • Missouri Baptist Outpatient Center-Sunset HillsRecruiting
  • Nebraska Cancer Specialists/Oncology Hematology West PC - MECCRecruiting
  • Nebraska Methodist HospitalRecruiting
  • Oncology Associates PCRecruiting
  • OptumCare Cancer Care at Seven HillsRecruiting
  • OptumCare Cancer Care at CharlestonRecruiting
  • OptumCare Cancer Care at Fort ApacheRecruiting
  • Englewood Hospital and Medical CenterRecruiting
  • Inspira Medical Center Mullica HillRecruiting
  • Vassar Brothers Medical CenterRecruiting
  • FirstHealth of the Carolinas-Moore Regional HospitalRecruiting
  • Strecker Cancer Center-BelpreRecruiting
  • Miami Valley Hospital SouthRecruiting
  • Adena Regional Medical CenterRecruiting
  • Mount Carmel East HospitalRecruiting
  • The Mark H Zangmeister CenterRecruiting
  • Miami Valley Hospital NorthRecruiting
  • Mount Carmel Grove City HospitalRecruiting
  • Fairfield Medical CenterRecruiting
  • Licking Memorial HospitalRecruiting
  • Mercy Health Perrysburg Cancer CenterRecruiting
  • Southern Ohio Medical CenterRecruiting
  • Springfield Regional Cancer CenterRecruiting
  • Mercy Health - Saint Anne HospitalRecruiting
  • Toledo Clinic Cancer Centers-ToledoRecruiting
  • Saint Ann's HospitalRecruiting
  • Genesis Healthcare System Cancer Care CenterRecruiting
  • Mercy Hospital Oklahoma CityRecruiting
  • Guthrie Medical Group PC-Robert Packer HospitalRecruiting
  • Women and Infants HospitalRecruiting
  • Lexington Medical CenterRecruiting
  • Bon Secours Memorial Regional Medical CenterRecruiting
  • Bon Secours Saint Francis Medical CenterRecruiting
  • Bon Secours Saint Mary's HospitalRecruiting
  • Valley Medical CenterRecruiting
  • North Star Lodge Cancer Center at Yakima Valley Memorial HospitalRecruiting
  • Edwards Comprehensive Cancer CenterRecruiting
  • Langlade Hospital and Cancer CenterRecruiting
  • ThedaCare Regional Cancer CenterRecruiting
  • ThedaCare Cancer Care - BerlinRecruiting
  • Mercyhealth Hospital and Cancer Center - JanesvilleRecruiting
  • Aspirus Medford HospitalRecruiting
  • ThedaCare Regional Medical Center - NeenahRecruiting
  • ThedaCare Cancer Care - New LondonRecruiting
  • ThedaCare Cancer Care - OshkoshRecruiting
  • Ascension Saint Mary's HospitalRecruiting
  • ThedaCare Cancer Care - ShawanoRecruiting
  • Ascension Saint Michael's HospitalRecruiting
  • ThedaCare Cancer Care - WaupacaRecruiting
  • Aspirus Regional Cancer CenterRecruiting
  • Aspirus Cancer Care - Wisconsin RapidsRecruiting
  • Doctors Cancer CenterRecruiting
  • San Juan City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (pembrolizumab)

Arm II (observation)

Arm Description

Patients receive pembrolizumab IV on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up.

Patients undergo observation on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up.

Outcomes

Primary Outcome Measures

Recurrence-free survival (RFS)
Defined as the time from randomization to first invasive local, regional, or distant recurrence or death due to any cause. RFS will be compared between treatment arms using the hazard ratio (with 90% confidence interval and stratified log-rank test) from a stratified Cox model.

Secondary Outcome Measures

Incidence of adverse events (AEs)
Adverse events will be determined using the latest version of the Common Terminology Criteria for Adverse Events (CTCAE). The proportions of patients with a grade 3 or higher AE will be compared between the arms using a chi-square test. A similar analysis will be done to compare the grade 3 or higher irAE rates
Overall survival
Defined as the time from randomization to death due to any cause. OS will be compared between treatment arms using the hazard ratio (and stratified log-rank test) from a stratified Cox model
Locoregional recurrence incidence
Defined as the time from randomization to first invasive local or regional recurrence. The cumulative incidence of LRR will be compared between treatment arms using a log-rank test (and estimated using Kaplan-Meier curves).
Radiation adverse events
Radiation adverse events include pneumonitis, hypothyroidism and dermatitis. Radiation AE event rates will be determined for patients who received radiation. The numerator is the number of patients with the radiation AE and the denominator is the number of patients who received radiation. The analysis of the radiation related adverse event rates will only include patients who received radiation treatment. The radiation AE rates will be compared between the two arms using a chi-square test.

Full Information

First Posted
March 23, 2023
Last Updated
August 2, 2023
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05812807
Brief Title
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
Official Title
OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
May 31, 2033 (Anticipated)
Study Completion Date
May 31, 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate whether observation results in a non-inferior recurrence-free survival (RFS) compared to adjuvant pembrolizumab in early-stage triple-negative breast cancer (TNBC) patients who achieve a pathologic complete response (pCR) after neoadjuvant chemotherapy with pembrolizumab. II. To compare quality of life (QOL) at approximately 27 weeks as assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B) Trial Outcome Index between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) III. To assess the social value of de-escalation of adjuvant breast cancer immunotherapy at approximately 27 weeks and, by modeling, over a lifetime. (Value of Care) SECONDARY OBJECTIVES: I. To evaluate whether observation compared to adjuvant pembrolizumab impacts the following: Ia. RFS by stage at presentation and by receipt of prior anthracycline therapy; Ib. Adverse event rate: difference in Grade 3 or higher adverse event rates overall and Grade 3 or higher immune-related adverse events (irAEs) rates; Ic. Overall Survival (OS); Id. Locoregional recurrence (LRR both isolated LRR as first events and LRR events simultaneous with DM); Ie. RFS, LRR, OS, adverse events, and QOL by age (=< 45, 46-65, and > 65), race, and ethnicity; If. Adverse events related to receipt of radiotherapy. II. To assess the value of de-escalation of breast cancer immunotherapy from the payer perspective at approximately 27 weeks and, by modelling, over a lifetime. (Value of Care) III. To compare patient out-of-pocket costs at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) IV. To compare financial toxicity at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) V. To compare work/productivity impairment at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) EXPLORATORY OBJECTIVES: I. To describe trajectories of QOL over time among patients randomized to adjuvant pembrolizumab versus (vs.) observation. (Quality of Life) II. To compare various QOL domains after approximately 27 weeks as assessed by the 5 subscales of the FACT-B Index between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) III. To compare self-reported symptomatic adverse events at approximately 27 weeks assessed by the patient reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) IV. To describe trajectories of financial toxicity and work/productivity impairment over time from baseline to approximately 27 weeks among patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) V. To develop and assess a measure of value from the patient perspective at approximately 27 weeks. (Value of Care) OUTLINE: Patients are randomized to 1 of 2 arms after completing neoadjuvant chemotherapy in combination with pembrolizumab, followed by definitive breast surgery. ARM I (PEMBROLIZUMAB): Patients receive pembrolizumab intravenously (IV) on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up. ARM II (OBSERVATION): Patients undergo observation on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Early Stage Triple-Negative Breast Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1295 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (pembrolizumab)
Arm Type
Active Comparator
Arm Description
Patients receive pembrolizumab IV on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up.
Arm Title
Arm II (observation)
Arm Type
Experimental
Arm Description
Patients undergo observation on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Patient Observation
Other Intervention Name(s)
Active surveillance, watchful waiting, observation
Intervention Description
Undergo observation
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Intervention Description
Undergo biopsy
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Intervention Description
Undergo collection of blood
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Recurrence-free survival (RFS)
Description
Defined as the time from randomization to first invasive local, regional, or distant recurrence or death due to any cause. RFS will be compared between treatment arms using the hazard ratio (with 90% confidence interval and stratified log-rank test) from a stratified Cox model.
Time Frame
Up to 10 years.
Secondary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Description
Adverse events will be determined using the latest version of the Common Terminology Criteria for Adverse Events (CTCAE). The proportions of patients with a grade 3 or higher AE will be compared between the arms using a chi-square test. A similar analysis will be done to compare the grade 3 or higher irAE rates
Time Frame
Up to 27 weeks after registration
Title
Overall survival
Description
Defined as the time from randomization to death due to any cause. OS will be compared between treatment arms using the hazard ratio (and stratified log-rank test) from a stratified Cox model
Time Frame
Up to 10 years.
Title
Locoregional recurrence incidence
Description
Defined as the time from randomization to first invasive local or regional recurrence. The cumulative incidence of LRR will be compared between treatment arms using a log-rank test (and estimated using Kaplan-Meier curves).
Time Frame
Up to 10 years.
Title
Radiation adverse events
Description
Radiation adverse events include pneumonitis, hypothyroidism and dermatitis. Radiation AE event rates will be determined for patients who received radiation. The numerator is the number of patients with the radiation AE and the denominator is the number of patients who received radiation. The analysis of the radiation related adverse event rates will only include patients who received radiation treatment. The radiation AE rates will be compared between the two arms using a chi-square test.
Time Frame
Up to 27 weeks after registration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 years Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 Triple Negative Breast Cancer: Patients with a history of stage T1cN1-2 or T2-4N0-2 breast cancer according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator in radiologic assessment, clinical assessment or both Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Isolated tumor cells are considered node-negative Estrogen (ER) and progesterone (PR) =< 10%; HER2-negative by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (immunohistochemistry [IHC] and fluorescence in situ hybridization [FISH]) If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy and ICI therapy should have been completed preoperatively An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization * Note: Adjuvant radiation can be given on study. If given, it is encouraged to be given concurrently with pembrolizumab, per investigator discretion. Treatment with adjuvant pembrolizumab is strongly discouraged prior to participation in this trial, but if administered (e.g., if patients are awaiting pathology results), pembrolizumab may be administered for up to 6 weeks post-surgery and must be completed prior to registration Use of investigational anti-cancer agents must be discontinued at time of registration Adequate excision: Surgical removal of all clinically evident disease in the breast and lymph nodes as follows: Breast surgery: Total mastectomy or breast-conserving surgery with histologically negative margins, including no ink on tumor for DCIS, at the time of excision ** For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of ductal carcinoma in-situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates DCIS at the line of resection, additional operative procedures may be performed to obtain clear margins. If DCIS is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection Lymph node surgery: For a patient with clinically N0 disease, a sentinel lymph node biopsy should have been performed at time of surgical evaluation, and if pathologically node positive, the patient is no longer eligible. Isolated tumor cells are considered node-negative For a patient with clinically N1 disease at diagnosis (with positive results from a fine-needle aspiration, core biopsy, or sentinel node biopsy performed prior to preoperative therapy) additional surgical evaluation of the axilla following preoperative therapy is required *** If they become cN0 (no palpable adenopathy), then a sentinel lymph node biopsy could have been performed at time of surgery (axillary dissection would also be permitted); if the sentinel lymph node biopsy is positive, the patient is no longer eligible If sentinel node biopsy performed before preoperative therapy was negative, no additional surgical evaluation of the axilla is required after preoperative therapy. If sentinel node biopsy performed before preoperative therapy was positive, an ALND is required after preoperative therapy If the only sentinel node identified by isotope scan is in the internal mammary chain, surgical evaluation of the axilla is still required If sentinel node evaluation after preoperative therapy is negative, no further additional surgical evaluation of the axilla is required Axillary dissection without sentinel node evaluation is permitted as the initial or sole axillary evaluation after preoperative therapy If breast-conserving surgery was performed but patient will not be receiving breast radiation, the patient is not eligible Not pregnant and not nursing, because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =< 7 days prior to randomization is required Absolute neutrophil count (ANC) >= 1,000/mm^3 Platelet Count >= 100,000/mm^3 Estimated glomerular filtration rate (eGFR) >= 15 mL/min/1.73m^2 Total Bilirubin =<1.5 x upper limit of normal (ULN) * Patients with Gilbert's disease with a total bilirubin =< 2.5 x ULN and direct bilirubin within normal limits are permitted Aspartate aminotransferase (AST) serum aspartate aminotransferase [SGOT] / alanine aminotransferase (ALT) serum glutamic pyruvic transaminase [SGPT] =< 3 x institutional ULN Patients must be willing to provide tumor tissue from the diagnostic core biopsy. If inadequate tumor tissue is available, patients are still eligible to participate in the trial Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial Exclusion Criteria: No stage IV (metastatic) breast cancer No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed No evidence of recurrent disease following preoperative therapy and surgery No known active liver disease, e.g. due to hepatitis B virus (HBV), hepatitis C virus (HCV), autoimmune hepatic disorders, or sclerosing cholangitis No history of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to pembrolizumab or murine proteins or any components of the product * Note: Prior immune-related adverse events (irAEs) are allowed if they resolved and the patient tolerated subsequent therapy without requiring chronic steroids for the irAE No medical conditions that require chronic systemic steroids (>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy Patients who are unable or unwilling to comply with the requirements of the protocol per investigator assessment are not eligible
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Tolaney, MD
Phone
617-632-2335
Email
Sara_Tolaney@dfci.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Hoffman
Phone
773-834-2546
Email
lhoffman22@bsd.uchicago.edu
Facility Information:
Facility Name
Thomas Hospital
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
251-435-4584
First Name & Middle Initial & Last Name & Degree
Jose N. Galeas
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
251-435-3942
First Name & Middle Initial & Last Name & Degree
Jose N. Galeas
Facility Name
Kingman Regional Medical Center
City
Kingman
State/Province
Arizona
ZIP/Postal Code
86401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Highlands Oncology Group - Fayetteville
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
479-872-8100
Email
research@hogonc.com
First Name & Middle Initial & Last Name & Degree
Joseph T. Beck
Facility Name
Highlands Oncology Group - Rogers
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
479-872-8130
Email
research@hogonc.com
First Name & Middle Initial & Last Name & Degree
Joseph T. Beck
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
479-872-8130
Email
research@hogonc.com
First Name & Middle Initial & Last Name & Degree
Joseph T. Beck
Facility Name
PCR Oncology
City
Arroyo Grande
State/Province
California
ZIP/Postal Code
93420
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Kaiser Permanente Dublin
City
Dublin
State/Province
California
ZIP/Postal Code
94568
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Kaiser Permanente-Fremont
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Kaiser Permanente-Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Kaiser Permanente-Modesto
City
Modesto
State/Province
California
ZIP/Postal Code
95356
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Kaiser Permanente-Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Kaiser Permanente-Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Kaiser Permanente Downtown Commons
City
Sacramento
State/Province
California
ZIP/Postal Code
95814
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Kaiser Permanente-South Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Kaiser Permanente-San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Kaiser Permanente-Santa Teresa-San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Kaiser Permanente San Leandro
City
San Leandro
State/Province
California
ZIP/Postal Code
94577
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Kaiser San Rafael-Gallinas
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Kaiser Permanente Medical Center - Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Saint John's Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
310-582-7448
First Name & Middle Initial & Last Name & Degree
Parvin F. Peddi
Facility Name
Kaiser Permanente-Santa Rosa
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Kaiser Permanente-South San Francisco
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Kaiser Permanente-Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Kaiser Permanente-Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Danbury Hospital
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-739-8074
First Name & Middle Initial & Last Name & Degree
Wenli Gao
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-852-2996
Email
jennifer.long@norwalkhealth.org
First Name & Middle Initial & Last Name & Degree
Lisa Phuong
Facility Name
Beebe South Coastal Health Campus
City
Frankford
State/Province
Delaware
ZIP/Postal Code
19945
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-291-6730
Email
research@beebehealthcare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-623-4450
Email
lbarone@christianacare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Medical Oncology Hematology Consultants PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-623-4450
Email
lbarone@christianacare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-291-6730
Email
research@beebehealthcare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
202-444-2223
First Name & Middle Initial & Last Name & Degree
Ami Chitalia
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
202-877-8839
First Name & Middle Initial & Last Name & Degree
Ami Chitalia
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
855-314-8646
First Name & Middle Initial & Last Name & Degree
Vijaya K. Gadiyaram
Facility Name
Mease Countryside Hospital
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
813-870-4760
Email
research.cto@baycare.org
First Name & Middle Initial & Last Name & Degree
Vijaya K. Gadiyaram
Facility Name
Saint Joseph's Hospital/Children's Hospital-Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
813-357-0849
Email
jennifer.manns@baycare.org
First Name & Middle Initial & Last Name & Degree
Vijaya K. Gadiyaram
Facility Name
Phoebe Putney Memorial Hospital
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
229-312-0405
Email
ga_cares@augusta.edu
First Name & Middle Initial & Last Name & Degree
Sharad A. Ghamande
Facility Name
Kaiser Permanente Moanalua Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
808-432-5195
Email
shelley.a.clark@kp.org
First Name & Middle Initial & Last Name & Degree
Jennifer M. Suga
Facility Name
Illinois CancerCare-Bloomington
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
309-243-3605
Email
andersonj@illinoiscancercare.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Illinois CancerCare-Canton
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
309-243-3605
Email
andersonj@illinoiscancercare.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Illinois CancerCare-Carthage
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
309-243-3605
Email
andersonj@illinoiscancercare.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Centralia Oncology Clinic
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-876-4762
Email
morganthaler.jodi@mhsil.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Carle at The Riverfront
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@Carle.com
First Name & Middle Initial & Last Name & Degree
Maria T. Grosse-Perdekamp
Facility Name
Cancer Care Specialists of Illinois - Decatur
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-876-4762
Email
morganthaler.jodi@mhsil.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-876-4762
Email
morganthaler.jodi@mhsil.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Illinois CancerCare-Dixon
City
Dixon
State/Province
Illinois
ZIP/Postal Code
61021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
815-285-7800
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Crossroads Cancer Center
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-876-4762
Email
morganthaler.jodi@mhsil.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Illinois CancerCare-Eureka
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
309-243-3605
Email
andersonj@illinoiscancercare.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Illinois CancerCare-Galesburg
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
309-243-3605
Email
andersonj@illinoiscancercare.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Illinois CancerCare-Kewanee Clinic
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
309-243-3605
Email
andersonj@illinoiscancercare.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Illinois CancerCare-Macomb
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
309-243-3605
Email
andersonj@illinoiscancercare.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Carle Physician Group-Mattoon/Charleston
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@carle.com
First Name & Middle Initial & Last Name & Degree
Maria T. Grosse-Perdekamp
Facility Name
Illinois CancerCare-Ottawa Clinic
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
309-243-3605
Email
andersonj@illinoiscancercare.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Illinois CancerCare-Pekin
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
309-243-3605
Email
andersonj@illinoiscancercare.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Illinois CancerCare-Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
309-243-3605
Email
andersonj@illinoiscancercare.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Illinois CancerCare-Peru
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
309-243-3605
Email
andersonj@illinoiscancercare.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Illinois CancerCare-Princeton
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
309-243-3605
Email
andersonj@illinoiscancercare.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-545-7929
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-444-7541
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-528-7541
Email
pallante.beth@mhsil.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@carle.com
First Name & Middle Initial & Last Name & Degree
Maria T. Grosse-Perdekamp
Facility Name
Illinois CancerCare - Washington
City
Washington
State/Province
Illinois
ZIP/Postal Code
61571
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
309-243-3605
Email
andersonj@illinoiscancercare.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Mercy Hospital
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
319-365-4673
First Name & Middle Initial & Last Name & Degree
Deborah W. Wilbur
Facility Name
Oncology Associates at Mercy Medical Center
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
319-363-2690
First Name & Middle Initial & Last Name & Degree
Deborah W. Wilbur
Facility Name
Jennie Edmundson Memorial Hospital
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-823-5923
Email
ctsucontact@westat.com
First Name & Middle Initial & Last Name & Degree
Kirsten M. Leu
Facility Name
Heartland Oncology and Hematology LLP
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
712-322-4136
First Name & Middle Initial & Last Name & Degree
Kirsten M. Leu
Facility Name
Cancer Center of Kansas - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
316-291-4774
Email
research@viachristi.org
First Name & Middle Initial & Last Name & Degree
Shaker R. Dakhil
Facility Name
Cancer Center of Kansas - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
316-291-4774
Email
research@viachristi.org
First Name & Middle Initial & Last Name & Degree
Shaker R. Dakhil
Facility Name
Cancer Center of Kansas - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
316-291-4774
Email
research@viachristi.org
First Name & Middle Initial & Last Name & Degree
Shaker R. Dakhil
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
316-291-4774
Email
research@viachristi.org
First Name & Middle Initial & Last Name & Degree
Shaker R. Dakhil
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
913-588-3671
Email
KUCC_Navigation@kumc.edu
First Name & Middle Initial & Last Name & Degree
Priyanka Sharma
Facility Name
Cancer Center of Kansas-Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
316-291-4774
Email
research@viachristi.org
First Name & Middle Initial & Last Name & Degree
Shaker R. Dakhil
Facility Name
Cancer Center of Kansas-Liberal
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
316-291-4774
Email
research@viachristi.org
First Name & Middle Initial & Last Name & Degree
Shaker R. Dakhil
Facility Name
Cancer Center of Kansas - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
316-291-4774
Email
research@viachristi.org
First Name & Middle Initial & Last Name & Degree
Shaker R. Dakhil
Facility Name
Olathe Health Cancer Center
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
913-355-8000
Email
Jeni.wakefield@olathehealth.org
First Name & Middle Initial & Last Name & Degree
Priyanka Sharma
Facility Name
University of Kansas Cancer Center-Overland Park
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
913-588-3671
Email
KUCC_Navigation@kumc.edu
First Name & Middle Initial & Last Name & Degree
Priyanka Sharma
Facility Name
University of Kansas Hospital-Indian Creek Campus
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
913-588-3671
Email
KUCC_Navigation@kumc.edu
First Name & Middle Initial & Last Name & Degree
Priyanka Sharma
Facility Name
Cancer Center of Kansas - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
316-291-4774
Email
research@viachristi.org
First Name & Middle Initial & Last Name & Degree
Shaker R. Dakhil
Facility Name
Cancer Center of Kansas - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
316-291-4774
Email
research@viachristi.org
First Name & Middle Initial & Last Name & Degree
Shaker R. Dakhil
Facility Name
Cancer Center of Kansas - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
316-291-4774
Email
research@viachristi.org
First Name & Middle Initial & Last Name & Degree
Shaker R. Dakhil
Facility Name
Cancer Center of Kansas - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
316-291-4774
Email
research@viachristi.org
First Name & Middle Initial & Last Name & Degree
Shaker R. Dakhil
Facility Name
University of Kansas Hospital-Westwood Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
913-588-3671
Email
KUCC_Navigation@kumc.edu
First Name & Middle Initial & Last Name & Degree
Priyanka Sharma
Facility Name
Cancer Center of Kansas-Wichita Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
316-291-4774
Email
research@viachristi.org
First Name & Middle Initial & Last Name & Degree
Shaker R. Dakhil
Facility Name
Ascension Via Christi Hospitals Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
316-291-4774
Email
research@viachristi.org
First Name & Middle Initial & Last Name & Degree
Shaker R. Dakhil
Facility Name
Cancer Center of Kansas - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
316-291-4774
Email
research@viachristi.org
First Name & Middle Initial & Last Name & Degree
Shaker R. Dakhil
Facility Name
Cancer Center of Kansas - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
316-291-4774
Email
research@viachristi.org
First Name & Middle Initial & Last Name & Degree
Shaker R. Dakhil
Facility Name
Ascension Providence Hospitals - Novi
City
Novi
State/Province
Michigan
ZIP/Postal Code
48374
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
248-849-5332
Email
karen.fife@ascension.org
First Name & Middle Initial & Last Name & Degree
Cynthia M. Vakhariya
Facility Name
Ascension Providence Hospitals - Southfield
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
248-849-5332
Email
karen.fife@ascension.org
First Name & Middle Initial & Last Name & Degree
Cynthia M. Vakhariya
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Daniel M. Anderson
Facility Name
Park Nicollet Clinic - Saint Louis Park
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Daniel M. Anderson
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
573-334-2230
Email
sfmc@sfmc.net
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Parkland Health Center - Farmington
City
Farmington
State/Province
Missouri
ZIP/Postal Code
63640
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-996-5569
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Truman Medical Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
816-404-4375
First Name & Middle Initial & Last Name & Degree
Priyanka Sharma
Facility Name
University of Kansas Cancer Center - North
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
913-588-3671
Email
KUCC_Navigation@kumc.edu
First Name & Middle Initial & Last Name & Degree
Priyanka Sharma
Facility Name
University of Kansas Cancer Center - Lee's Summit
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64064
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
913-588-3671
Email
KUCC_Navigation@kumc.edu
First Name & Middle Initial & Last Name & Degree
Priyanka Sharma
Facility Name
University of Kansas Cancer Center at North Kansas City Hospital
City
North Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
913-588-3671
Email
KUCC_Navigation@kumc.edu
First Name & Middle Initial & Last Name & Degree
Priyanka Sharma
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Nusayba Bagegni
Facility Name
Missouri Baptist Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-996-5569
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Sainte Genevieve County Memorial Hospital
City
Sainte Genevieve
State/Province
Missouri
ZIP/Postal Code
63670
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-996-5569
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
417-269-4520
First Name & Middle Initial & Last Name & Degree
Jay W. Carlson
Facility Name
Missouri Baptist Sullivan Hospital
City
Sullivan
State/Province
Missouri
ZIP/Postal Code
63080
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-996-5569
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Missouri Baptist Outpatient Center-Sunset Hills
City
Sunset Hills
State/Province
Missouri
ZIP/Postal Code
63127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-996-5569
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
402-334-4773
First Name & Middle Initial & Last Name & Degree
Kirsten M. Leu
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
402-354-5144
First Name & Middle Initial & Last Name & Degree
Kirsten M. Leu
Facility Name
Oncology Associates PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
402-354-5860
Email
info@oa-oc.com
First Name & Middle Initial & Last Name & Degree
Kirsten M. Leu
Facility Name
OptumCare Cancer Care at Seven Hills
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
OptumCare Cancer Care at Charleston
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
OptumCare Cancer Care at Fort Apache
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
201-894-3456
First Name & Middle Initial & Last Name & Degree
Jill S. Morrison
Facility Name
Inspira Medical Center Mullica Hill
City
Mullica Hill
State/Province
New Jersey
ZIP/Postal Code
08062
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
856-508-3500
Email
DeNigrisJ@ihn.org
First Name & Middle Initial & Last Name & Degree
Erev E. Tubb
Facility Name
Vassar Brothers Medical Center
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
845-483-6483
First Name & Middle Initial & Last Name & Degree
Stephen C. Malamud
Facility Name
FirstHealth of the Carolinas-Moore Regional Hospital
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
910-715-3500
Email
jcwilliams@firsthealth.org
First Name & Middle Initial & Last Name & Degree
Charles S. Kuzma
Facility Name
Strecker Cancer Center-Belpre
City
Belpre
State/Province
Ohio
ZIP/Postal Code
45714
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-523-3977
Email
sheree@columbusccop.org
First Name & Middle Initial & Last Name & Degree
Timothy D. Moore
Facility Name
Miami Valley Hospital South
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Jhansi L. Koduri
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
45601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-779-7585
Email
sheree@columbusccop.org
First Name & Middle Initial & Last Name & Degree
Timothy D. Moore
Facility Name
Mount Carmel East Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
614-488-2118
Email
sheree@columbusccop.org
First Name & Middle Initial & Last Name & Degree
Timothy D. Moore
Facility Name
The Mark H Zangmeister Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
614-488-2118
Email
sheree@columbusccop.org
First Name & Middle Initial & Last Name & Degree
Timothy D. Moore
Facility Name
Miami Valley Hospital North
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Jhansi L. Koduri
Facility Name
Mount Carmel Grove City Hospital
City
Grove City
State/Province
Ohio
ZIP/Postal Code
43123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-779-7585
Email
sheree@columbusccop.org
First Name & Middle Initial & Last Name & Degree
Timothy D. Moore
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
740-687-8863
Email
sheree@columbusccop.org
First Name & Middle Initial & Last Name & Degree
Timothy D. Moore
Facility Name
Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
740-348-4000
Email
sheree@columbusccop.org
First Name & Middle Initial & Last Name & Degree
Timothy D. Moore
Facility Name
Mercy Health Perrysburg Cancer Center
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
614-488-2118
Email
sheree@columbusccop.org
First Name & Middle Initial & Last Name & Degree
Timothy D. Moore
Facility Name
Southern Ohio Medical Center
City
Portsmouth
State/Province
Ohio
ZIP/Postal Code
45662
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
614-488-2118
Email
sheree@columbusccop.org
First Name & Middle Initial & Last Name & Degree
Timothy D. Moore
Facility Name
Springfield Regional Cancer Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Timothy D. Moore
Facility Name
Mercy Health - Saint Anne Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
614-488-2118
Email
sheree@columbusccop.org
First Name & Middle Initial & Last Name & Degree
Timothy D. Moore
Facility Name
Toledo Clinic Cancer Centers-Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-444-3561
First Name & Middle Initial & Last Name & Degree
Rex B. Mowat
Facility Name
Saint Ann's Hospital
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
614-234-5433
Email
sheree@columbusccop.org
First Name & Middle Initial & Last Name & Degree
Timothy D. Moore
Facility Name
Genesis Healthcare System Cancer Care Center
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
740-454-5232
Email
sheree@columbusccop.org
First Name & Middle Initial & Last Name & Degree
Timothy D. Moore
Facility Name
Mercy Hospital Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
405-752-3402
First Name & Middle Initial & Last Name & Degree
Jay W. Carlson
Facility Name
Guthrie Medical Group PC-Robert Packer Hospital
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-836-0388
First Name & Middle Initial & Last Name & Degree
Joyson Poulose
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
401-274-1122
First Name & Middle Initial & Last Name & Degree
William M. Sikov
Facility Name
Lexington Medical Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
803-791-2105
Email
LMCIRB@lexhealth.org
First Name & Middle Initial & Last Name & Degree
Steven A. Madden
Facility Name
Bon Secours Memorial Regional Medical Center
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
804-893-8978
Email
anne_carmellat@bshsi.org
First Name & Middle Initial & Last Name & Degree
William J. Irvin
Facility Name
Bon Secours Saint Francis Medical Center
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
804-893-8978
Email
anne_carmellat@bshsi.org
First Name & Middle Initial & Last Name & Degree
William J. Irvin
Facility Name
Bon Secours Saint Mary's Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
804-893-8978
Email
anne_carmellat@bshsi.org
First Name & Middle Initial & Last Name & Degree
William J. Irvin
Facility Name
Valley Medical Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
425-228-3440
Email
research@valleymed.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
509-574-3535
Email
Memorial-ClinicalTrials@yvmh.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Edwards Comprehensive Cancer Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
304-399-6566
Email
Christina.Cole@chhi.org
First Name & Middle Initial & Last Name & Degree
Maria R. Tria Tirona
Facility Name
Langlade Hospital and Cancer Center
City
Antigo
State/Province
Wisconsin
ZIP/Postal Code
54409
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
715-623-9869
Email
Juli.Alford@aspirus.org
First Name & Middle Initial & Last Name & Degree
Andrew J. Huang
Facility Name
ThedaCare Regional Cancer Center
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54911
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
920-364-3604
Email
ResearchDept@thedacare.org
First Name & Middle Initial & Last Name & Degree
Shannon Schmidt
Facility Name
ThedaCare Cancer Care - Berlin
City
Berlin
State/Province
Wisconsin
ZIP/Postal Code
54923
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
920-364-3605
Email
ResearchDept@thedacare.org
First Name & Middle Initial & Last Name & Degree
Shannon Schmidt
Facility Name
Mercyhealth Hospital and Cancer Center - Janesville
City
Janesville
State/Province
Wisconsin
ZIP/Postal Code
53548
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
608-756-6871
Email
oncologyclinicaltrials@mhemail.org
First Name & Middle Initial & Last Name & Degree
Emily G. Robinson
Facility Name
Aspirus Medford Hospital
City
Medford
State/Province
Wisconsin
ZIP/Postal Code
54451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
715-847-2353
Email
Beth.Knetter@aspirus.org
First Name & Middle Initial & Last Name & Degree
Andrew J. Huang
Facility Name
ThedaCare Regional Medical Center - Neenah
City
Neenah
State/Province
Wisconsin
ZIP/Postal Code
54956
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
920-364-3605
Email
ResearchDept@thedacare.org
First Name & Middle Initial & Last Name & Degree
Shannon Schmidt
Facility Name
ThedaCare Cancer Care - New London
City
New London
State/Province
Wisconsin
ZIP/Postal Code
54961
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
920-364-3605
Email
ResearchDept@thedacare.org
First Name & Middle Initial & Last Name & Degree
Shannon Schmidt
Facility Name
ThedaCare Cancer Care - Oshkosh
City
Oshkosh
State/Province
Wisconsin
ZIP/Postal Code
54904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
920-364-3605
Email
ResearchDept@thedacare.org
First Name & Middle Initial & Last Name & Degree
Shannon Schmidt
Facility Name
Ascension Saint Mary's Hospital
City
Rhinelander
State/Province
Wisconsin
ZIP/Postal Code
54501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
715-847-2353
Email
Beth.Knetter@aspirus.org
First Name & Middle Initial & Last Name & Degree
Andrew J. Huang
Facility Name
ThedaCare Cancer Care - Shawano
City
Shawano
State/Province
Wisconsin
ZIP/Postal Code
54166
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
920-364-3605
Email
ResearchDept@thedacare.org
First Name & Middle Initial & Last Name & Degree
Shannon Schmidt
Facility Name
Ascension Saint Michael's Hospital
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54481
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
715-847-2353
Email
Beth.Knetter@aspirus.org
First Name & Middle Initial & Last Name & Degree
Andrew J. Huang
Facility Name
ThedaCare Cancer Care - Waupaca
City
Waupaca
State/Province
Wisconsin
ZIP/Postal Code
54981
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
920-364-3605
Email
ResearchDept@thedacare.org
First Name & Middle Initial & Last Name & Degree
Shannon Schmidt
Facility Name
Aspirus Regional Cancer Center
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-405-6866
First Name & Middle Initial & Last Name & Degree
Andrew J. Huang
Facility Name
Aspirus Cancer Care - Wisconsin Rapids
City
Wisconsin Rapids
State/Province
Wisconsin
ZIP/Postal Code
54494
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
715-422-7718
First Name & Middle Initial & Last Name & Degree
Andrew J. Huang
Facility Name
Doctors Cancer Center
City
Manati
ZIP/Postal Code
00674
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
787-621-4397
First Name & Middle Initial & Last Name & Degree
Luis J. Santos Reyes
Facility Name
San Juan City Hospital
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
787-763-1296
First Name & Middle Initial & Last Name & Degree
Luis J. Santos Reyes

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab

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