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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab (K): IV infusion Q3W
Placebo (P): Normal saline or dextrose IV infusion Q3W
Paclitaxel (X): IV infusion QW
Doxorubicin (A): IV infusion either in Q2W or Q3W
Epirubicin (E): IV infusion either in Q2W or Q3W
Cyclophosphamide (C): IV infusion either in Q2W or Q3W
Endocrine therapy: Variable endocrine therapy for up 10 years
Radiation therapy: Variable radiation therapy per local standard of care
Surgery: Surgery for breast cancer
Study summary
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.
Eligibility
Primary outcome measure(s)
- Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0 — Up to approximately 7 months (Time of surgery)
The pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by American Joint Committee on Cancer (AJCC) staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pathological Complete Response (pCR) using the definition of (ypT0/Tis ypN0) will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies. - Event-Free Survival (EFS) — Up to approximately 12 years
EFS is defined as the time from randomization to disease progression that: precludes surgery, results in a local or distant recurrence, results in a second primary malignancy, or death due to any cause whichever occurs first. The EFS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies, as determined by the investigator will be presented.
Trial sites (244)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | |
| Weill Cornell Medical College ( Site 0043) | New York | New York | |
| CTCA Southwestern ( Site 0074) | Tulsa | Oklahoma | |
| OHSU Knight Cancer Institute ( Site 0051) | Portland | Oregon | |
| Northwest Cancer Specialists, P.C. ( Site 8000) | Tigard | Oregon | |
| Geisinger Medical Center ( Site 0052) | Danville | Pennsylvania | |
| Fox Chase Cancer Center ( Site 0078) | Philadelphia | Pennsylvania | |
| Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0076) | Philadelphia | Pennsylvania | |
| Medical University of South Carolina ( Site 0053) | Charleston | South Carolina | |
| Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 7000) | Nashville | Tennessee | |
| Texas Oncology-Austin Central ( Site 8004) | Austin | Texas | |
| Texas Oncology-Dallas Presbyterian Hospital ( Site 8002) | Dallas | Texas | |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8009) | Dallas | Texas | |
| Texas Oncology-Memorial City ( Site 8012) | Houston | Texas | |
| University of Texas-MD Anderson Cancer Center ( Site 0083) | Houston | Texas | |
| Texas Oncology- Plano East ( Site 8010) | Plano | Texas |
+ 204 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03725059 on ClinicalTrials.gov ↗ ← All trials in South Korea