RESEARCH STUDIES & Clinical Trials

Clinical Trial ID: NCT02954874 S1418/BR006, A Randomized, Phase III Trial to Evaluate The Efficacy and Safety of MK-3475 (PEMBROLIZUMAB) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy




This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.


To compare invasive disease-free survival (IDFS) of patients with triple-negative breast cancer (TNBC) who have either >1 cm residual invasive breast cancer and/or positive lymph nodes (>ypN+) after neoadjuvant chemotherapy randomized to receive 1 year of MK-3475 (pembrolizumab) adjuvant therapy compared to no MK-3475 (pembrolizumab), in both the entire study population and also in the PDL1 positive subset.


Experimental: Observation Patients receive no treatment but are monitored at standard clinical intervals during first year after randomization. Patients are examined every 12 weeks for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients may undergo radiation therapy within 12 weeks of last breast cancer operation or after treatment. Experimental: Pembrolizumab Patients receive pembrolizumab IV over 30 minutes on days 1 and 22. Courses repeat every 42 days for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients may undergo radiation therapy within 12 weeks of last breast cancer operation or after treatment.







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Main Investiagtor

Crozier, Jennifer





Participating Institutions

Baptist MD Anderson Cancer Center


Eligibility Criteria: - Patients must have histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR)- and HER2-negative (triple-negative, TNBC) or ER, PR, and HER2 equivocal status and must not have received and not be planning to receive adjuvant anti-HER2 or endocrine therapies after completion of neoadjuvant chemotherapy; patients who are HER2 positive by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines are ineligible - Patients must not have metastatic disease (i.e., must be M0); patients must not have locally recurrent disease - Patients must have a minimum of five, available unstained slides from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node; (these will be submitted to determine PD-L1 expression) the tumor tissue must be adequate for PD-L1 testing, which typically requires a minimum of 100 cancer cells per slide - Patients must be offered the opportunity to participate in specimen banking - Patients must have had neoadjuvant chemotherapy followed by surgery; the recommended neoadjuvant treatment should include 16-24 weeks of a third generation chemotherapy regimen as recommended by National Comprehensive Cancer Network (NCCN) guidelines for triple negative breast cancer (examples include dose dense adriamycin-cytoxan [AC] followed by dose-dense paclitaxel - Patients may receive post-operative (adjuvant) chemotherapy for up to 24 weeks of duration (e.g. 8 cycles of capecitabine as in the CREATE-X trial) after completion of surgery at the discretion of the treating physician - Patients for whom radiation therapy (RT) to the affected breast or chest wall and regional nodal areas is clinically indicated as per NCCN treatment guidelines, should receive RT after randomization when possible, and receive MK-3475 (pembrolizumab) concurrent with RT, if randomized to the experimental arm; however, RT administered, or initiated, prior to registration is also allowed - Patients must not have had prior immunotherapy with anti-PD-L1, anti-PD-1, anti-CTLA4 or similar drugs; patients must not be planning to receive any of the prohibited therapies during the screening or treatment phases of the study - Patients must not be planning to receive concomitantly other biologic therapy, hormonal therapy, other chemotherapy, surgery or other anti-cancer therapy except radiation therapy while receiving treatment on this protocol - Patients must have Zubrod performance status =< 2 - Patients must not have a history of (non-infectious) pneumonitis that required steroids or evidence of active pneumonitis - Patients must not have an active infection requiring systemic therapy - Patients must not have active autoimmune disease that has required systemic treatment in past 2 years - Patients must not have received live vaccines within 30 days prior to registration - Patients must not have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection prior to registration - No other prior invasive malignancy is allowed except for the following: adequately treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer; stage I or II invasive cancer treated with a curative intent without evidence of disease recurrence for at least five years - Patients must have complete history and physical examination within 28 days prior to registration - Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines - Other eligibility criteria may apply per study protocol

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