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)
Public ClinicalTrials.gov record NCT03725059. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03725059
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,240 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab (K) Biological
- Placebo (P) Drug
- Paclitaxel (X) Drug
- Doxorubicin (A) Drug
- Epirubicin (E) Drug
- Cyclophosphamide (C) Drug
- Endocrine therapy Drug
- Radiation therapy Radiation
- Surgery Procedure
Biological · Drug · Radiation + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 26, 2018
- Primary completion
- Jan 23, 2031
- Completion
- Jan 23, 2031
- Last update posted
- Jul 10, 2025
2018 – 2031
United States locations
- U.S. sites
- 45
- U.S. states
- 26
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern Cancer Center, PC ( Site 8003) | Daphne | Alabama | 36526 | — |
| Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001) | Goodyear | Arizona | 85338 | — |
| Arizona Oncology Associates PC- HOPE ( Site 8008) | Tucson | Arizona | 85704 | — |
| Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079) | Los Angeles | California | 90048 | — |
| El Camino Hospital Cancer Center ( Site 0004) | Mountain View | California | 94040 | — |
| Stanford Cancer Center ( Site 0072) | Palo Alto | California | 94304 | — |
| UC Davis Comprehensive Cancer Center ( Site 0073) | Sacramento | California | 95817 | — |
| University of Colorado, Anschutz Cancer Pavilion ( Site 0008) | Aurora | Colorado | 80045 | — |
| Baptist MD Anderson Cancer Center ( Site 0014) | Jacksonville | Florida | 32207 | — |
| Southeastern Regional Medical Center, Inc. ( Site 0075) | Newnan | Georgia | 30265 | — |
| The University of Chicago Medical Center ( Site 0080) | Chicago | Illinois | 60637 | — |
| Orchard Healthcare Research Inc. ( Site 0020) | Skokie | Illinois | 60077 | — |
| Midwestern Regional Medical Center, Inc. ( Site 0077) | Zion | Illinois | 60099 | — |
| Goshen Center for Cancer Care ( Site 0021) | Goshen | Indiana | 46526 | — |
| MercyOne Waterloo Cancer Center ( Site 0016) | Waterloo | Iowa | 50702 | — |
| James Graham Brown Cancer Center ( Site 0022) | Louisville | Kentucky | 40202 | — |
| Maryland Oncology Hematology, P.A. ( Site 8007) | Bethesda | Maryland | 20817 | — |
| Massachusetts General Hospital ( Site 0024) | Boston | Massachusetts | 02114 | — |
| MGH - North Shore Cancer Center ( Site 0081) | Danvers | Massachusetts | 01923 | — |
| MGH Newton-Wellesley Hospital's Vernon Cancer Center ( Site 0082) | Newton | Massachusetts | 02462 | — |
| Henry Ford Health System ( Site 0028) | Detroit | Michigan | 48202 | — |
| Mayo Clinic and Medical School (Rochester) ( Site 0029) | Rochester | Minnesota | 55905 | — |
| St. Vincent Frontier Cancer Center ( Site 0033) | Billings | Montana | 59102 | — |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0039) | Omaha | Nebraska | 68130 | — |
| Holy Name Medical Center ( Site 0041) | Teaneck | New Jersey | 07666 | — |
| Weill Cornell Medical College ( Site 0043) | New York | New York | 10065 | — |
| CTCA Southwestern ( Site 0074) | Tulsa | Oklahoma | 74133 | — |
| OHSU Knight Cancer Institute ( Site 0051) | Portland | Oregon | 97239 | — |
| Northwest Cancer Specialists, P.C. ( Site 8000) | Tigard | Oregon | 97223 | — |
| Geisinger Medical Center ( Site 0052) | Danville | Pennsylvania | 17822 | — |
| Fox Chase Cancer Center ( Site 0078) | Philadelphia | Pennsylvania | 19111 | — |
| Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0076) | Philadelphia | Pennsylvania | 19124 | — |
| Medical University of South Carolina ( Site 0053) | Charleston | South Carolina | 29425 | — |
| Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 7000) | Nashville | Tennessee | 37203 | — |
| Texas Oncology-Austin Central ( Site 8004) | Austin | Texas | 78731 | — |
| Texas Oncology-Dallas Presbyterian Hospital ( Site 8002) | Dallas | Texas | 75231 | — |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8009) | Dallas | Texas | 75246 | — |
| Texas Oncology-Memorial City ( Site 8012) | Houston | Texas | 77024 | — |
| University of Texas-MD Anderson Cancer Center ( Site 0083) | Houston | Texas | 77030 | — |
| Texas Oncology- Plano East ( Site 8010) | Plano | Texas | 75075 | — |
| Texas Oncology - Northeast Texas ( Site 8006) | Tyler | Texas | 75702 | — |
| Bon Secours St. Francis Medical Center Oncology Research ( Site 0064) | Midlothian | Virginia | 23114 | — |
| Virginia Oncology Associates ( Site 8001) | Norfolk | Virginia | 23502 | — |
| Kadlec Clinic Hematology and Oncology ( Site 0070) | Kennewick | Washington | 99336 | — |
| Medical Oncology Associates (Summit Cancer Centers) ( Site 0066) | Spokane | Washington | 99208 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 199 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03725059, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 10, 2025 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03725059 live on ClinicalTrials.gov.