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Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery

Primary Purpose

Male Breast Carcinoma, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
Lapatinib Ditosylate
Paclitaxel
Trastuzumab
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Breast Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Pathologic confirmation of invasive breast cancer; patients with inflammatory breast cancer are not eligible

  • Clinical stage II-III operable invasive breast cancer with intent to perform surgical resection after neoadjuvant therapy

    • Patients with multicentric or bilateral disease are eligible as long as the target lesion meets the eligibility criteria for this study
    • Staging to rule out metastatic disease is recommended for clinical stage III patients
  • Tumors must be HER2 positive defined as HER2 3+ by immunohistochemical (IHC) assays or gene amplification by fluorescence in situ hybridization (FISH) with a ratio of >= 2 on invasive tumor
  • Estrogen receptor (ER) and progesterone receptor (PgR) status must be known
  • The target lesion in the breast must be >= 1 cm on physical examination or by radiographic measurement; palpable axillary adenopathy will be documented but not serve as measurable disease for the primary endpoint; patients with axillary disease only are not eligible to participate
  • Patient agrees to provide pretreatment biopsies
  • No prior chemotherapy, hormone therapy, biologic, or radiation therapy with therapeutic intent for this cancer
  • Cardiac ejection fraction must be >= 50% by echocardiogram or multiple gated acquisition (MUGA) scan
  • Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
  • Patients must not be pregnant or nursing
  • Absolute neutrophil count (ANC) >= 1,000/ul
  • Platelet count >= 100,000/ul
  • Bilirubin =< 1.5 times upper limit of normal
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper limit of normal (ULN)
  • Serum beta-human chorionic gonadotropin (HCG) negative (in female patients unless status-post (s/p) hysterectomy or menopausal or no menses for 24 consecutive months); assay must have a sensitivity of at least 50 mIU/mL

Sites / Locations

  • Banner University Medical Center - Tucson
  • Sparks Regional Medical Center
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • East Bay Radiation Oncology Center
  • Eden Hospital Medical Center
  • Valley Medical Oncology Consultants-Castro Valley
  • Bay Area Breast Surgeons Inc
  • Valley Medical Oncology Consultants-Fremont
  • Contra Costa Regional Medical Center
  • El Camino Hospital
  • Palo Alto Medical Foundation-Camino Division
  • Highland General Hospital
  • Alta Bates Summit Medical Center - Summit Campus
  • Bay Area Tumor Institute
  • Hematology and Oncology Associates-Oakland
  • Tom K Lee Inc
  • Desert Regional Medical Center
  • Palo Alto Medical Foundation Health Care
  • Valley Care Health System - Pleasanton
  • Valley Medical Oncology Consultants
  • University of California Davis Comprehensive Cancer Center
  • Saint Helena Hospital
  • Salinas Valley Memorial
  • Zuckerberg San Francisco General Hospital
  • UCSF Medical Center-Mount Zion
  • Doctors Medical Center- JC Robinson Regional Cancer Center
  • The Medical Center of Aurora
  • Boulder Community Hospital
  • Penrose-Saint Francis Healthcare
  • Porter Adventist Hospital
  • Presbyterian - Saint Lukes Medical Center - Health One
  • SCL Health Saint Joseph Hospital
  • Rose Medical Center
  • Western States Cancer Research NCORP
  • Swedish Medical Center
  • Saint Mary's Hospital and Regional Medical Center
  • North Colorado Medical Center
  • Saint Anthony Hospital
  • Littleton Adventist Hospital
  • Sky Ridge Medical Center
  • Longmont United Hospital
  • McKee Medical Center
  • Parker Adventist Hospital
  • Saint Mary Corwin Medical Center
  • North Suburban Medical Center
  • SCL Health Lutheran Medical Center
  • Smilow Cancer Hospital Care Center at Saint Francis
  • Manchester Memorial Hospital
  • Middlesex Hospital
  • Beebe Medical Center
  • Christiana Care Health System-Christiana Hospital
  • MedStar Georgetown University Hospital
  • Halifax Health Medical Center-Centers for Oncology
  • Holy Cross Hospital
  • Florida Cancer Specialists-Gainesville Cancer Center
  • Jupiter Medical Center
  • Mount Sinai Medical Center
  • Cleveland Clinic-Weston
  • Piedmont Hospital
  • Atlanta Regional CCOP
  • Emory Saint Joseph's Hospital
  • Northside Hospital
  • WellStar Cobb Hospital
  • John B Amos Cancer Center
  • Dekalb Medical Center
  • Piedmont Fayette Hospital
  • Northside Hospital - Gwinnett
  • Medical Center of Central Georgia
  • Wellstar Kennestone Hospital
  • Southern Regional Medical Center
  • Harbin Clinic Medical Oncology and Clinical Research
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  • Saint Alphonsus Cancer Care Center-Boise
  • Saint Anthony's Health
  • Mount Sinai Hospital Medical Center
  • University of Illinois
  • Presence Resurrection Medical Center
  • University of Chicago Comprehensive Cancer Center
  • Weiss Memorial Hospital
  • Advocate Good Samaritan Hospital
  • Duly Health and Care Joliet
  • Loyola University Medical Center
  • Good Samaritan Regional Health Center
  • Advocate Christ Medical Center
  • Swedish American Hospital
  • Franciscan Saint Francis Health-Beech Grove
  • Fort Wayne Medical Oncology and Hematology Inc-Parkview
  • Reid Health
  • McFarland Clinic - Ames
  • University of Iowa Healthcare Cancer Services Quad Cities
  • Medical Oncology and Hematology Associates-West Des Moines
  • Mercy Capitol
  • Iowa Methodist Medical Center
  • Iowa-Wide Oncology Research Coalition NCORP
  • Medical Oncology and Hematology Associates-Des Moines
  • Mercy Medical Center - Des Moines
  • Mission Cancer and Blood - Laurel
  • Iowa Lutheran Hospital
  • University of Iowa/Holden Comprehensive Cancer Center
  • Siouxland Regional Cancer Center
  • Mercy Medical Center-Sioux City
  • Saint Luke's Regional Medical Center
  • HaysMed University of Kansas Health System
  • Hutchinson Regional Medical Center
  • University of Kansas Cancer Center
  • Ascension Via Christi - Pittsburg
  • Salina Regional Health Center
  • Cotton O'Neil Cancer Center / Stormont Vail Health
  • University of Kansas Health System Saint Francis Campus
  • Harold Alfond Center for Cancer Care
  • Eastern Maine Medical Center
  • University of Maryland/Greenebaum Cancer Center
  • Walter Reed National Military Medical Center
  • Christiana Care - Union Hospital
  • TidalHealth Peninsula Regional
  • Holy Cross Hospital
  • Sturdy Memorial Hospital
  • Tufts Medical Center
  • Massachusetts General Hospital Cancer Center
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Steward Saint Elizabeth's Medical Center
  • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
  • Newton-Wellesley Hospital
  • Michigan Cancer Research Consortium NCORP
  • Saint Joseph Mercy Hospital
  • University of Michigan Comprehensive Cancer Center
  • Beaumont Hospital - Dearborn
  • Ascension Saint John Hospital
  • Hurley Medical Center
  • Genesys Regional Medical Center-West Flint Campus
  • Genesys Regional Medical Center
  • Allegiance Health
  • Bronson Methodist Hospital
  • West Michigan Cancer Center
  • Borgess Medical Center
  • Sparrow Hospital
  • Trinity Health Saint Mary Mercy Livonia Hospital
  • Saint Joseph Mercy Oakland
  • Lake Huron Medical Center
  • Ascension Saint Mary's Hospital
  • Ascension Providence Hospitals - Southfield
  • Saint John Macomb-Oakland Hospital
  • Mayo Clinic Health Systems-Mankato
  • Southeast Missouri Hospital
  • Saint Francis Medical Center
  • Southeast Cancer Center
  • Capital Region Southwest Campus
  • Truman Medical Centers
  • Saint Louis Cancer and Breast Institute-South City
  • Washington University School of Medicine
  • Missouri Baptist Medical Center
  • Center for Cancer Care and Research
  • Comprehensive Cancer Care PC
  • Mercy Hospital Saint Louis
  • Saint Louis-Cape Girardeau CCOP
  • Billings Clinic Cancer Center
  • Northern Rockies Radiation Oncology Center
  • Saint Vincent Healthcare
  • Montana Cancer Consortium NCORP
  • Saint Vincent Frontier Cancer Center
  • Bozeman Deaconess Hospital
  • Saint James Community Hospital and Cancer Treatment Center
  • Benefis Healthcare- Sletten Cancer Institute
  • Berdeaux, Donald MD (UIA Investigator)
  • Great Falls Clinic
  • Northern Montana Hospital
  • Saint Peter's Community Hospital
  • Glacier Oncology PLLC
  • Kalispell Medical Oncology
  • Kalispell Regional Medical Center
  • Montana Cancer Specialists
  • Saint Patrick Hospital - Community Hospital
  • Community Medical Hospital
  • Guardian Oncology and Center for Wellness
  • Nebraska Cancer Research Center
  • Missouri Valley Cancer Consortium
  • Alegent Health Immanuel Medical Center
  • Alegent Health Bergan Mercy Medical Center
  • Alegent Health Lakeside Hospital
  • Creighton University Medical Center
  • University Medical Center of Southern Nevada
  • Nevada Cancer Research Foundation NCORP
  • Renown Regional Medical Center
  • New Hampshire Oncology Hematology PA-Concord
  • Cheshire Medical Center-Dartmouth-Hitchcock Keene
  • LRGHealthcare-Lakes Region General Hospital
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
  • Norris Cotton Cancer Center-Manchester
  • Elliot Hospital
  • Solinsky Center for Cancer Care
  • Foundation Medical Partners
  • Cooper Hospital University Medical Center
  • Morristown Medical Center
  • Rutgers New Jersey Medical School
  • Overlook Hospital
  • Lovelace Medical Center-Saint Joseph Square
  • University of New Mexico Cancer Center
  • Hematology Oncology Associates
  • Roswell Park Cancer Institute
  • Hematology Oncology Associates of Central New York-East Syracuse
  • Elmhurst Hospital Center
  • Queens Hospital Center
  • Northwell Health NCORP
  • Northwell Health/Center for Advanced Medicine
  • North Shore University Hospital
  • Garnet Health Medical Center
  • Long Island Jewish Medical Center
  • Memorial Sloan Kettering Cancer Center
  • Vassar Brothers Medical Center
  • State University of New York Upstate Medical University
  • Mission Hospital
  • Cone Health Cancer Center at Alamance Regional
  • UNC Lineberger Comprehensive Cancer Center
  • Atrium Health Cabarrus/LCI-Concord
  • Duke University Medical Center
  • Wayne Memorial Hospital
  • East Carolina University
  • Vidant Oncology-Kinston
  • FirstHealth of the Carolinas-Moore Regional Hospital
  • UNC Rex Healthcare
  • Marion L Shepard Cancer Center at Vidant Beaufort Hospital
  • Wake Forest University Health Sciences
  • Mid Dakota Clinic
  • Saint Alexius Medical Center
  • Sanford Bismarck Medical Center
  • Cleveland Clinic Akron General
  • Cleveland Clinic Cancer Center Beachwood
  • Aultman Health Foundation
  • Cleveland Clinic Cancer Center/Fairview Hospital
  • Cleveland Clinic Foundation
  • Ohio State University Comprehensive Cancer Center
  • Grandview Hospital
  • Good Samaritan Hospital - Dayton
  • Miami Valley Hospital
  • Miami Valley Hospital North
  • Dayton NCI Community Oncology Research Program
  • Blanchard Valley Hospital
  • Atrium Medical Center-Middletown Regional Hospital
  • Wayne Hospital
  • Cleveland Clinic Cancer Center Independence
  • Kettering Medical Center
  • Saint Rita's Medical Center
  • Hillcrest Hospital Cancer Center
  • University Hospitals Parma Medical Center
  • Cleveland Clinic Cancer Center Strongsville
  • Upper Valley Medical Center
  • Clinton Memorial Hospital
  • Cleveland Clinic Wooster Family Health and Surgery Center
  • Greene Memorial Hospital
  • University of Oklahoma Health Sciences Center
  • Cancer Care Associates
  • UPMC Hillman Cancer Center Erie
  • Penn State Milton S Hershey Medical Center
  • Lewistown Hospital
  • Guthrie Medical Group PC-Robert Packer Hospital
  • Mount Nittany Medical Center
  • Kent Hospital
  • Prisma Health Cancer Institute - Spartanburg
  • Roper Hospital
  • Prisma Health Cancer Institute - Easley
  • Greenville Health System Cancer Institute-Andrews
  • Saint Francis Hospital
  • Prisma Health Cancer Institute - Butternut
  • Prisma Health Cancer Institute - Faris
  • Prisma Health Greenville Memorial Hospital
  • Prisma Health Cancer Institute - Eastside
  • Self Regional Healthcare
  • Prisma Health Cancer Institute - Greer
  • Prisma Health Cancer Institute - Seneca
  • Lexington Medical Center
  • Erlanger Medical Center
  • Nashville Oncology Associates PC
  • Meharry Medical College
  • Doctor's Hospital of Laredo
  • Texas Tech University Health Sciences Center-Lubbock
  • Central Vermont Medical Center/National Life Cancer Treatment
  • University of Vermont and State Agricultural College
  • Danville Regional Medical Center
  • Hematology Oncology Associates of Fredericksburg Inc
  • Centra Lynchburg Hematology-Oncology Clinic Inc
  • Cancer Care Center at Island Hospital
  • MultiCare Auburn Medical Center
  • PeaceHealth Saint Joseph Medical Center
  • Harrison HealthPartners Hematology and Oncology-Bremerton
  • Highline Medical Center-Main Campus
  • Providence Regional Cancer System-Centralia
  • Saint Francis Hospital
  • Kadlec Clinic Hematology and Oncology
  • EvergreenHealth Medical Center
  • Saint Clare Hospital
  • Skagit Valley Hospital
  • Providence - Saint Peter Hospital
  • Harrison HealthPartners Hematology and Oncology-Poulsbo
  • MultiCare Good Samaritan Hospital
  • Virginia Mason Medical Center
  • Minor and James Medical PLLC
  • Pacific Medical Center-First Hill
  • Kaiser Permanente Washington
  • Swedish Medical Center-First Hill
  • University of Washington Medical Center - Montlake
  • PeaceHealth United General Medical Center
  • Cancer Care Northwest - Spokane South
  • Providence Sacred Heart Medical Center and Children's Hospital
  • Providence Holy Family Hospital
  • Evergreen Hematology and Oncology PS
  • MultiCare Allenmore Hospital
  • MultiCare Tacoma General Hospital
  • Northwest NCI Community Oncology Research Program
  • Saint Joseph Medical Center
  • Wenatchee Valley Hospital and Clinics
  • Saint Mary's Medical Center
  • Camden Clark Medical Center
  • Gundersen Lutheran Medical Center
  • Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
  • Welch Cancer Center
  • San Juan City Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Arm I (THL)

Arm II (TH)

Arm III (TL)

Arm Description

Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.

Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.

Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)

Outcomes

Primary Outcome Measures

pCR Rate
Complete pathological response is defined as the absence of residual invasive carcinoma in the breast at the time of definitive surgical removal. Pathologic complete response in the lymph nodes is defined as no detectable invasive tumor by H&E. Analysis will use a chi-square test for the difference in proportions of patients on the THL arm versus the TH arm who achieve a pCR. Exact binomial methods will be used to construct 95% confidence intervals around the pCR incidence for each arm.

Secondary Outcome Measures

Pathologic Stage in the Breast and Axilla
Stage will be determined by the American Joint Committee on Cancer (AJCC) TNM (tumor, lymph nodes, metastasis) staging system.
Radiographic Response Rate (at Completion of Neoadjuvant Therapy)
Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions).
Overall Survival
Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method
Relapse-free Survival (RFS)
Relapse free survival is defined as the interval from definitive surgery to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, or death from any cause, whichever occurs first. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Patients who do not undergo definitive surgery will not be assessable for RFS. Distribution was estimated using the Kaplan Meier product-limit method.
Time to First Failure
Time to first failure is defined as the interval from study entry to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence or death from any cause. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Distribution was estimated using the Kaplan Meier product-limit method.
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3
The type and grade of treatment-related toxicity will be tabulated by treatment arm.

Full Information

First Posted
October 9, 2008
Last Updated
September 12, 2023
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00770809
Brief Title
Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery
Official Title
Randomized Phase III Trial of Paclitaxel +Trastuzumab + Lapatinib Versus Paclitaxel + Trastuzumab as Neoadjuvant Treatment of HER2-Positive Primary Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2008 (Actual)
Primary Completion Date
January 31, 2014 (Actual)
Study Completion Date
July 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib to see how well they work in treating patients with stage II or stage III breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel with trastuzumab and/or lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which regimen is more effective in treating patients with breast cancer.
Detailed Description
PRIMARY OBJECTIVE: I. To determine if the pathologic complete response (pCR) in the breast to neoadjuvant weekly paclitaxel with trastuzumab plus lapatinib (THL) is 20% greater than the pCR to weekly paclitaxel with trastuzumab alone (TH). SECONDARY OBJECTIVES: I. To determine the pathologic complete response in the breast and axilla, using American Joint Committee on Cancer (AJCC) Tumor, Lymph Nodes and Metastasis (TMN) criteria (version 6), to neoadjuvant weekly paclitaxel plus human epidermal growth factor 2 (HER2)- targeted therapy in patients with HER2-positive operable breast cancer. II. To evaluate residual cancer burden (RCB) as a predictor of long term relapse free survival (RFS) and overall survival (OS). III. To document the toxicity of all chemotherapeutic regimens (THL, TH). IV. To determine the correlation between clinical, radiographic and pathologic response. V. To compare overall survival (OS), relapse free survival (RFS) and time to first failure (TFF) among the treatment groups. VI. To obtain blood, fresh frozen and fixed tumor tissue to test specific hypotheses for which biomarker data exist and to evaluate biomarkers in blood, serum and tissue that are likely to influence response to and toxicity of trastuzumab alone or trastuzumab plus lapatinib, when given with paclitaxel. VII. To determine the surgical practice patterns for breast conservation and sentinel lymphadenectomy in patients undergoing neoadjuvant chemotherapy. VIII. To determine the radiotherapy practice patterns for post-mastectomy and regional nodal irradiation in patients undergoing neoadjuvant chemotherapy. IX. To evaluate pharmacogenomic determinants of toxicity. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive trastuzumab IV over 30-90 minutes and paclitaxel IV over 1 hour once weekly and lapatinib ditosylate orally (PO) once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive trastuzumab and paclitaxel as in arm I. ARM III: Patients receive paclitaxel and lapatinib ditosylate as in arm I. (Discontinued as of 6-15-11) Within 42 days after completion of neoadjuvant therapy, patients in both arms undergo definitive surgery (breast conservation or total mastectomy). After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 10 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Breast Carcinoma, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arm I (THL)
Arm Type
Experimental
Arm Description
Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm II (TH)
Arm Type
Active Comparator
Arm Description
Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm III (TL)
Arm Type
Experimental
Arm Description
Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
Lapatinib Ditosylate
Other Intervention Name(s)
Tykerb
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
ABP 980, ALT02, Biceltis, CANMab, CT-P06, CT-P6, Herceptin, Herceptin Biosimilar PF-05280014, Herceptin Trastuzumab Biosimilar PF-05280014, Herclon, Hertraz, Herzuma, Kanjinti, Ogivri, Ontruzant, PF-05280014, QL 1701, QL-1701, QL1701, rhuMAb HER2, RO0452317, SB3, Trastuzumab Biosimilar ABP 980, Trastuzumab Biosimilar ALT02, Trastuzumab Biosimilar CT-P6, trastuzumab biosimilar EG12014, Trastuzumab Biosimilar HLX02, Trastuzumab Biosimilar PF-05280014, Trastuzumab Biosimilar QL1701, Trastuzumab Biosimilar SB3, Trastuzumab Biosimilar SIBP-01, Trastuzumab-anns, Trastuzumab-dkst, Trastuzumab-dttb, Trastuzumab-pkrb, Trastuzumab-qyyp, Trazimera
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
pCR Rate
Description
Complete pathological response is defined as the absence of residual invasive carcinoma in the breast at the time of definitive surgical removal. Pathologic complete response in the lymph nodes is defined as no detectable invasive tumor by H&E. Analysis will use a chi-square test for the difference in proportions of patients on the THL arm versus the TH arm who achieve a pCR. Exact binomial methods will be used to construct 95% confidence intervals around the pCR incidence for each arm.
Time Frame
At time of surgery
Secondary Outcome Measure Information:
Title
Pathologic Stage in the Breast and Axilla
Description
Stage will be determined by the American Joint Committee on Cancer (AJCC) TNM (tumor, lymph nodes, metastasis) staging system.
Time Frame
At time of surgery
Title
Radiographic Response Rate (at Completion of Neoadjuvant Therapy)
Description
Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions).
Time Frame
Week 16
Title
Overall Survival
Description
Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method
Time Frame
Time from randomization to death or last follow-up (up to 10 years)
Title
Relapse-free Survival (RFS)
Description
Relapse free survival is defined as the interval from definitive surgery to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, or death from any cause, whichever occurs first. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Patients who do not undergo definitive surgery will not be assessable for RFS. Distribution was estimated using the Kaplan Meier product-limit method.
Time Frame
Time from surgery to any recurrence (up to 10 years)
Title
Time to First Failure
Description
Time to first failure is defined as the interval from study entry to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence or death from any cause. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Distribution was estimated using the Kaplan Meier product-limit method.
Time Frame
Time from study entry to any recurrence ( up to 10 years)
Title
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3
Description
The type and grade of treatment-related toxicity will be tabulated by treatment arm.
Time Frame
Up to 30 days post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologic confirmation of invasive breast cancer; patients with inflammatory breast cancer are not eligible Clinical stage II-III operable invasive breast cancer with intent to perform surgical resection after neoadjuvant therapy Patients with multicentric or bilateral disease are eligible as long as the target lesion meets the eligibility criteria for this study Staging to rule out metastatic disease is recommended for clinical stage III patients Tumors must be HER2 positive defined as HER2 3+ by immunohistochemical (IHC) assays or gene amplification by fluorescence in situ hybridization (FISH) with a ratio of >= 2 on invasive tumor Estrogen receptor (ER) and progesterone receptor (PgR) status must be known The target lesion in the breast must be >= 1 cm on physical examination or by radiographic measurement; palpable axillary adenopathy will be documented but not serve as measurable disease for the primary endpoint; patients with axillary disease only are not eligible to participate Patient agrees to provide pretreatment biopsies No prior chemotherapy, hormone therapy, biologic, or radiation therapy with therapeutic intent for this cancer Cardiac ejection fraction must be >= 50% by echocardiogram or multiple gated acquisition (MUGA) scan Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1 Patients must not be pregnant or nursing Absolute neutrophil count (ANC) >= 1,000/ul Platelet count >= 100,000/ul Bilirubin =< 1.5 times upper limit of normal Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper limit of normal (ULN) Serum beta-human chorionic gonadotropin (HCG) negative (in female patients unless status-post (s/p) hysterectomy or menopausal or no menses for 24 consecutive months); assay must have a sensitivity of at least 50 mIU/mL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa A Carey
Organizational Affiliation
Alliance for Clinical Trials in Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Sparks Regional Medical Center
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
Facility Name
Providence Saint Joseph Medical Center/Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
East Bay Radiation Oncology Center
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Eden Hospital Medical Center
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Valley Medical Oncology Consultants-Castro Valley
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Bay Area Breast Surgeons Inc
City
Emeryville
State/Province
California
ZIP/Postal Code
94608
Country
United States
Facility Name
Valley Medical Oncology Consultants-Fremont
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Contra Costa Regional Medical Center
City
Martinez
State/Province
California
ZIP/Postal Code
94553-3156
Country
United States
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Palo Alto Medical Foundation-Camino Division
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Highland General Hospital
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States
Facility Name
Alta Bates Summit Medical Center - Summit Campus
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Hematology and Oncology Associates-Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Tom K Lee Inc
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Desert Regional Medical Center
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Palo Alto Medical Foundation Health Care
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
Facility Name
Valley Care Health System - Pleasanton
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Facility Name
Valley Medical Oncology Consultants
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Saint Helena Hospital
City
Saint Helena
State/Province
California
ZIP/Postal Code
94574
Country
United States
Facility Name
Salinas Valley Memorial
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
Zuckerberg San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
UCSF Medical Center-Mount Zion
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Doctors Medical Center- JC Robinson Regional Cancer Center
City
San Pablo
State/Province
California
ZIP/Postal Code
94806
Country
United States
Facility Name
The Medical Center of Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Penrose-Saint Francis Healthcare
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Presbyterian - Saint Lukes Medical Center - Health One
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
SCL Health Saint Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Western States Cancer Research NCORP
City
Denver
State/Province
Colorado
ZIP/Postal Code
80222
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Saint Mary's Hospital and Regional Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
North Colorado Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
Saint Anthony Hospital
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Littleton Adventist Hospital
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
McKee Medical Center
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80539
Country
United States
Facility Name
Parker Adventist Hospital
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
Saint Mary Corwin Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
North Suburban Medical Center
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
SCL Health Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Smilow Cancer Hospital Care Center at Saint Francis
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Manchester Memorial Hospital
City
Manchester
State/Province
Connecticut
ZIP/Postal Code
06040
Country
United States
Facility Name
Middlesex Hospital
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Halifax Health Medical Center-Centers for Oncology
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Florida Cancer Specialists-Gainesville Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Cleveland Clinic-Weston
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Atlanta Regional CCOP
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
WellStar Cobb Hospital
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
John B Amos Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Dekalb Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Piedmont Fayette Hospital
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Northside Hospital - Gwinnett
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Medical Center of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Southern Regional Medical Center
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
Harbin Clinic Medical Oncology and Clinical Research
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center-Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Saint Anthony's Health
City
Alton
State/Province
Illinois
ZIP/Postal Code
62002
Country
United States
Facility Name
Mount Sinai Hospital Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Presence Resurrection Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60631
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Advocate Good Samaritan Hospital
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States
Facility Name
Duly Health and Care Joliet
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Good Samaritan Regional Health Center
City
Mount Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453-2699
Country
United States
Facility Name
Swedish American Hospital
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61104
Country
United States
Facility Name
Franciscan Saint Francis Health-Beech Grove
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology Inc-Parkview
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Reid Health
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
McFarland Clinic - Ames
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
University of Iowa Healthcare Cancer Services Quad Cities
City
Bettendorf
State/Province
Iowa
ZIP/Postal Code
52722
Country
United States
Facility Name
Medical Oncology and Hematology Associates-West Des Moines
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Mercy Capitol
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50307
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Iowa-Wide Oncology Research Coalition NCORP
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mission Cancer and Blood - Laurel
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Siouxland Regional Cancer Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center-Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51102
Country
United States
Facility Name
Saint Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
HaysMed University of Kansas Health System
City
Hays
State/Province
Kansas
ZIP/Postal Code
67601
Country
United States
Facility Name
Hutchinson Regional Medical Center
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Ascension Via Christi - Pittsburg
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Cotton O'Neil Cancer Center / Stormont Vail Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
University of Kansas Health System Saint Francis Campus
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Harold Alfond Center for Cancer Care
City
Augusta
State/Province
Maine
ZIP/Postal Code
04330
Country
United States
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
University of Maryland/Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889-5600
Country
United States
Facility Name
Christiana Care - Union Hospital
City
Elkton
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
TidalHealth Peninsula Regional
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21801
Country
United States
Facility Name
Holy Cross Hospital
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Sturdy Memorial Hospital
City
Attleboro
State/Province
Massachusetts
ZIP/Postal Code
02703
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Steward Saint Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Michigan Cancer Research Consortium NCORP
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Beaumont Hospital - Dearborn
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Ascension Saint John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Genesys Regional Medical Center-West Flint Campus
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Allegiance Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Trinity Health Saint Mary Mercy Livonia Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
Saint Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Lake Huron Medical Center
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Ascension Saint Mary's Hospital
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Ascension Providence Hospitals - Southfield
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Saint John Macomb-Oakland Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Mayo Clinic Health Systems-Mankato
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56001
Country
United States
Facility Name
Southeast Missouri Hospital
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63701
Country
United States
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Southeast Cancer Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Capital Region Southwest Campus
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Truman Medical Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Saint Louis Cancer and Breast Institute-South City
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Missouri Baptist Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Center for Cancer Care and Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Comprehensive Cancer Care PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Saint Louis-Cape Girardeau CCOP
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Northern Rockies Radiation Oncology Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Saint Vincent Healthcare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Montana Cancer Consortium NCORP
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Saint Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Saint James Community Hospital and Cancer Treatment Center
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Benefis Healthcare- Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Berdeaux, Donald MD (UIA Investigator)
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Northern Montana Hospital
City
Havre
State/Province
Montana
ZIP/Postal Code
59501
Country
United States
Facility Name
Saint Peter's Community Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Montana Cancer Specialists
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Saint Patrick Hospital - Community Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Community Medical Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Guardian Oncology and Center for Wellness
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Nebraska Cancer Research Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Alegent Health Immanuel Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68122
Country
United States
Facility Name
Alegent Health Bergan Mercy Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Alegent Health Lakeside Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Nevada Cancer Research Foundation NCORP
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
New Hampshire Oncology Hematology PA-Concord
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
Cheshire Medical Center-Dartmouth-Hitchcock Keene
City
Keene
State/Province
New Hampshire
ZIP/Postal Code
03431
Country
United States
Facility Name
LRGHealthcare-Lakes Region General Hospital
City
Laconia
State/Province
New Hampshire
ZIP/Postal Code
03246
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Norris Cotton Cancer Center-Manchester
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Facility Name
Elliot Hospital
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03103
Country
United States
Facility Name
Solinsky Center for Cancer Care
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03103
Country
United States
Facility Name
Foundation Medical Partners
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Cooper Hospital University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
Facility Name
Overlook Hospital
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07902
Country
United States
Facility Name
Lovelace Medical Center-Saint Joseph Square
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Hematology Oncology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Hematology Oncology Associates of Central New York-East Syracuse
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Elmhurst Hospital Center
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
Queens Hospital Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Northwell Health NCORP
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Northwell Health/Center for Advanced Medicine
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Garnet Health Medical Center
City
Middletown
State/Province
New York
ZIP/Postal Code
10940
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Vassar Brothers Medical Center
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
State University of New York Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Cone Health Cancer Center at Alamance Regional
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Atrium Health Cabarrus/LCI-Concord
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wayne Memorial Hospital
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Vidant Oncology-Kinston
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
FirstHealth of the Carolinas-Moore Regional Hospital
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
UNC Rex Healthcare
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Marion L Shepard Cancer Center at Vidant Beaufort Hospital
City
Washington
State/Province
North Carolina
ZIP/Postal Code
27889
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Mid Dakota Clinic
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Saint Alexius Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Sanford Bismarck Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Cleveland Clinic Akron General
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Cleveland Clinic Cancer Center Beachwood
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Aultman Health Foundation
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Cleveland Clinic Cancer Center/Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Miami Valley Hospital North
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Dayton NCI Community Oncology Research Program
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Blanchard Valley Hospital
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Atrium Medical Center-Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Facility Name
Wayne Hospital
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Facility Name
Cleveland Clinic Cancer Center Independence
City
Independence
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Saint Rita's Medical Center
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
Hillcrest Hospital Cancer Center
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
University Hospitals Parma Medical Center
City
Parma
State/Province
Ohio
ZIP/Postal Code
44129
Country
United States
Facility Name
Cleveland Clinic Cancer Center Strongsville
City
Strongsville
State/Province
Ohio
ZIP/Postal Code
44136
Country
United States
Facility Name
Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Facility Name
Clinton Memorial Hospital
City
Wilmington
State/Province
Ohio
ZIP/Postal Code
45177
Country
United States
Facility Name
Cleveland Clinic Wooster Family Health and Surgery Center
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cancer Care Associates
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
UPMC Hillman Cancer Center Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Lewistown Hospital
City
Lewistown
State/Province
Pennsylvania
ZIP/Postal Code
17044
Country
United States
Facility Name
Guthrie Medical Group PC-Robert Packer Hospital
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Mount Nittany Medical Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16803
Country
United States
Facility Name
Kent Hospital
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Prisma Health Cancer Institute - Spartanburg
City
Boiling Springs
State/Province
South Carolina
ZIP/Postal Code
29316
Country
United States
Facility Name
Roper Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Prisma Health Cancer Institute - Easley
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Greenville Health System Cancer Institute-Andrews
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Saint Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Prisma Health Cancer Institute - Butternut
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Cancer Institute - Faris
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Cancer Institute - Eastside
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Self Regional Healthcare
City
Greenwood
State/Province
South Carolina
ZIP/Postal Code
29646
Country
United States
Facility Name
Prisma Health Cancer Institute - Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Prisma Health Cancer Institute - Seneca
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
Lexington Medical Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Erlanger Medical Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Nashville Oncology Associates PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
Doctor's Hospital of Laredo
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Texas Tech University Health Sciences Center-Lubbock
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Central Vermont Medical Center/National Life Cancer Treatment
City
Berlin
State/Province
Vermont
ZIP/Postal Code
05602
Country
United States
Facility Name
University of Vermont and State Agricultural College
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Hematology Oncology Associates of Fredericksburg Inc
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22408
Country
United States
Facility Name
Centra Lynchburg Hematology-Oncology Clinic Inc
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Cancer Care Center at Island Hospital
City
Anacortes
State/Province
Washington
ZIP/Postal Code
98221
Country
United States
Facility Name
MultiCare Auburn Medical Center
City
Auburn
State/Province
Washington
ZIP/Postal Code
98001
Country
United States
Facility Name
PeaceHealth Saint Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Harrison HealthPartners Hematology and Oncology-Bremerton
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Highline Medical Center-Main Campus
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Providence Regional Cancer System-Centralia
City
Centralia
State/Province
Washington
ZIP/Postal Code
98531
Country
United States
Facility Name
Saint Francis Hospital
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
EvergreenHealth Medical Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Saint Clare Hospital
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Skagit Valley Hospital
City
Mount Vernon
State/Province
Washington
ZIP/Postal Code
98274
Country
United States
Facility Name
Providence - Saint Peter Hospital
City
Olympia
State/Province
Washington
ZIP/Postal Code
98506-5166
Country
United States
Facility Name
Harrison HealthPartners Hematology and Oncology-Poulsbo
City
Poulsbo
State/Province
Washington
ZIP/Postal Code
98370
Country
United States
Facility Name
MultiCare Good Samaritan Hospital
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Minor and James Medical PLLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Pacific Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Kaiser Permanente Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University of Washington Medical Center - Montlake
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
PeaceHealth United General Medical Center
City
Sedro-Woolley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Facility Name
Cancer Care Northwest - Spokane South
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Providence Sacred Heart Medical Center and Children's Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Providence Holy Family Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Evergreen Hematology and Oncology PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
MultiCare Allenmore Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
MultiCare Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Northwest NCI Community Oncology Research Program
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Saint Joseph Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Wenatchee Valley Hospital and Clinics
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Saint Mary's Medical Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25702
Country
United States
Facility Name
Camden Clark Medical Center
City
Parkersburg
State/Province
West Virginia
ZIP/Postal Code
26101
Country
United States
Facility Name
Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53210
Country
United States
Facility Name
Welch Cancer Center
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States
Facility Name
San Juan City Hospital
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
33095682
Citation
Fernandez-Martinez A, Krop IE, Hillman DW, Polley MY, Parker JS, Huebner L, Hoadley KA, Shepherd J, Tolaney S, Henry NL, Dang C, Harris L, Berry D, Hahn O, Hudis C, Winer E, Partridge A, Perou CM, Carey LA. Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer. J Clin Oncol. 2020 Dec 10;38(35):4184-4193. doi: 10.1200/JCO.20.01276. Epub 2020 Oct 23.
Results Reference
derived
PubMed Identifier
26527775
Citation
Carey LA, Berry DA, Cirrincione CT, Barry WT, Pitcher BN, Harris LN, Ollila DW, Krop IE, Henry NL, Weckstein DJ, Anders CK, Singh B, Hoadley KA, Iglesia M, Cheang MC, Perou CM, Winer EP, Hudis CA. Molecular Heterogeneity and Response to Neoadjuvant Human Epidermal Growth Factor Receptor 2 Targeting in CALGB 40601, a Randomized Phase III Trial of Paclitaxel Plus Trastuzumab With or Without Lapatinib. J Clin Oncol. 2016 Feb 20;34(6):542-9. doi: 10.1200/JCO.2015.62.1268. Epub 2015 Nov 2.
Results Reference
derived

Learn more about this trial

Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery

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