Endocrine Treatment of Breast Cancer
common.study.values.description
“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-) breast cancer. 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.
common.study.values.location
participant.ui.study.affiliations-map.online-study.header-virtual
participant.ui.study.affiliations-map.online-study.text
common.study.values.methods
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-yes
Biological - Pembrolizumab (K)
IV infusion Q3W
Drug - Placebo (P)
Normal saline or dextrose IV infusion Q3W
Drug - Paclitaxel (X)
IV infusion QW
Drug - Doxorubicin (A)
IV infusion Q3W
Drug - Epirubicin (E)
IV infusion Q3W
Drug - Cyclophosphamide (C)
IV infusion Q3W
Drug - Endocrine therapy
Variable endocrine therapy for up 10 years
Radiation - Radiation therapy
Variable radiation therapy per local standard of care
Procedure - Surgery
Definitive surgery for breast cancer
participant.views.study.view.additional
participant.views.study.view.scientific-title
A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (KEYNOTE-756)
common.study.values.clinical-trial-id
NCT03725059
participant.views.study.view.id
aOYZNd
