Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
About this trial
This is an interventional treatment trial for Anatomic Stage I Breast Cancer AJCC v8
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
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
Active Comparator
Experimental
Arm I (pembrolizumab)
Arm II (observation)
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.