Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475)
versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant
(post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage
estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-)
The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in
combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by
pathological Complete Response (pCR) rate defined by the local pathologist, and 2)
pembrolizumab is superior to placebo (both in combination with the protocol-specified
neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as
determined by the investigator. The study is considered to have met its primary objective if
pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.
Study participants will receive 8 cycles of neoadjuvant study treatment and then will undergo
surgery for their breast cancer. After surgery, participants will receive 9 cycles of study
treatment and up to 10 years of variable endocrine therapy. Each cycle is 21 days long.
Breast Cancer Diagnosis,
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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