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) (NCT03725059)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Southern Cancer Center, PC ( Site 8003) — Daphne, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (244 Sites)
Showing the first 25 of 244 sites.
- Southern Cancer Center, PC ( Site 8003) — Daphne, Alabama
- Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001) — Goodyear, Arizona
- Arizona Oncology Associates PC- HOPE ( Site 8008) — Tucson, Arizona
- Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079) — Los Angeles, California
- El Camino Hospital Cancer Center ( Site 0004) — Mountain View, California
- Stanford Cancer Center ( Site 0072) — Palo Alto, California
- UC Davis Comprehensive Cancer Center ( Site 0073) — Sacramento, California
- University of Colorado, Anschutz Cancer Pavilion ( Site 0008) — Aurora, Colorado
- Baptist MD Anderson Cancer Center ( Site 0014) — Jacksonville, Florida
- Southeastern Regional Medical Center, Inc. ( Site 0075) — Newnan, Georgia
- The University of Chicago Medical Center ( Site 0080) — Chicago, Illinois
- Orchard Healthcare Research Inc. ( Site 0020) — Skokie, Illinois
- Midwestern Regional Medical Center, Inc. ( Site 0077) — Zion, Illinois
- Goshen Center for Cancer Care ( Site 0021) — Goshen, Indiana
- MercyOne Waterloo Cancer Center ( Site 0016) — Waterloo, Iowa
- James Graham Brown Cancer Center ( Site 0022) — Louisville, Kentucky
- Maryland Oncology Hematology, P.A. ( Site 8007) — Bethesda, Maryland
- Massachusetts General Hospital ( Site 0024) — Boston, Massachusetts
- MGH - North Shore Cancer Center ( Site 0081) — Danvers, Massachusetts
- MGH Newton-Wellesley Hospital's Vernon Cancer Center ( Site 0082) — Newton, Massachusetts
- Henry Ford Health System ( Site 0028) — Detroit, Michigan
- Mayo Clinic and Medical School (Rochester) ( Site 0029) — Rochester, Minnesota
- St. Vincent Frontier Cancer Center ( Site 0033) — Billings, Montana
- Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0039) — Omaha, Nebraska
- Holy Name Medical Center ( Site 0041) — Teaneck, New Jersey
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.