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)
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)
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).
After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence.
The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.
Inclusion Criteria:
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.
Has previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee of Cancer (AJCC) staging criteria for breast cancer as assessed by the investigator based on radiological and/or clinical assessment:
Provides a core needle biopsy consisting of at least 2 separate tumor cores from the primary tumor at screening to the central laboratory.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of treatment initiation.
Demonstrates adequate organ function.
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.
Exclusion Criteria:
Scottsdale, Arizona 85268, United States
Miami, Florida 33176, United States
Cincinnati, Ohio 45220, United States
Dallas, Texas 75246, United States
Midlothian, Virginia 23114, United States
Spokane, Washington 99208, United States
Yakima, Washington 98902, United States
Franskton, 3199, Australia
Cascavel, 85806-300, Brazil
São José do Rio Preto, 15090-000, Brazil
Québec, Quebec G1S 4L8, Canada
Beer Yaakov-Zerifin, 7030001, Israel
Brescia, 25100, Italy
Kitaadachi-gun, Saitama 362-0806, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Gliwice, Silesian Voivodeship 44-101, Poland
Porto, 4200-072, Portugal
Ufa, 450054, Russia
Samsun, Atakum 55280, Turkey (Türkiye)
Ankara, 06200, Turkey (Türkiye)
Antalya, 07020, Turkey (Türkiye)
Edirne, 22030, Turkey (Türkiye)
Izmir, 35040, Turkey (Türkiye)
Izmir, 35575, Turkey (Türkiye)