Clinical Trial

Endocrine Treatment of Breast Cancer

Study 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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

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

Additional Information

Official Study 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)

Clinical Trial ID

NCT03725059

ParticipAid ID

aOYZNd