![]() ![]() Has known active Hepatitis B or Hepatitis C. Has a known history of Human Immunodeficiency Virus (HIV). Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Has received a live vaccine within 30 days of the first dose of study treatment. Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 4 weeks of the first dose of treatment in this current study. Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4, OX-40, CD137 ) or has previously participated in a pembrolizumab (MK-3475) clinical study. Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months. Males and female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and 6 months after the last dose of study treatment for participants who did not.Ĭritères de non-inclusion : - Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of treatment initiation. Provides a core needle biopsy consisting of at least 2 separate tumor cores from the primary tumor at screening to the central laboratory. Has previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per American Joint Committee of Cancer (AJCC) Breast Cancer Staging Version 7 as assessed by the investigator based on radiological and/or clinical assessment: Each cycle is 21 days.Ĭritères d'inclusion : - Has newly diagnosed, locally advanced, centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. Participants receive placebo (normal saline solution) Q3W + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by placebo + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery followed by 9 cycles of placebo Q3W as adjuvant therapy post-surgery. ![]() ![]() Active Comparator: Placebo + Chemotherapy Participants receive pembrolizumab every 3 weeks (Q3W) + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by pembrolizumab Q3W + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery followed by 9 cycles of pembrolizumab Q3W as adjuvant therapy post-surgery. Experimental: Pembrolizumab + Chemotherapy Schéma : A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC) ![]()
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