Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
Public ClinicalTrials.gov record NCT04895358. 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, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1. Prior to protocol amendment 7, participants who discontinued pembrolizumab/placebo with SD or better and subsequently experienced disease progression may have been eligible for up to 17 additional administrations of pembrolizumab if, upon unblinding, they were found to have received pembrolizumab, at the same dose and schedule used for the initial treatment period.
Study identification
- NCT ID
- NCT04895358
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 342 participants
Conditions and interventions
Conditions
Interventions
- pembrolizumab Biological
- paclitaxel Drug
- nab-paclitaxel Drug
- liposomal doxorubicin Drug
- capecitabine Drug
- normal saline Drug
- dextrose Drug
Biological · Drug
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
- Jun 18, 2021 (Actual)
- Primary completion
- Apr 24, 2026 (Actual)
- Completion
- Dec 18, 2027 (Estimated)
- Last update posted
- Jul 22, 2026
2021 – 2027
United States locations
- U.S. sites
- 41
- U.S. states
- 24
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham-Medicine ( Site 0065) | Birmingham | Alabama | 35294-3300 | — |
| Arizona Oncology Associates-Arizona Oncology ( Site 0049) | Tucson | Arizona | 85711 | — |
| Pacific Cancer Care ( Site 0023) | Monterey | California | 93940 | — |
| UCSF Medical Center at Mission Bay ( Site 0043) | San Francisco | California | 94158 | — |
| Georgetown University Medical Center-Department of Medicine and Oncology ( Site 0026) | Washington D.C. | District of Columbia | 20007 | — |
| MedStar Washington Hospital Center ( Site 0063) | Washington D.C. | District of Columbia | 20010 | — |
| Baptist MD Anderson Cancer Center ( Site 0013) | Jacksonville | Florida | 32207 | — |
| Miami Cancer Institute at Baptist Health, Inc. ( Site 0070) | Miami | Florida | 33176 | — |
| Miami Cancer Institute - Plantation ( Site 0076) | Plantation | Florida | 33324 | — |
| University Cancer & Blood Center, LLC ( Site 0032) | Athens | Georgia | 30607 | — |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0028) | Marietta | Georgia | 30060 | — |
| University of Illinois at Chicago ( Site 0061) | Chicago | Illinois | 60612 | — |
| Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0067) | Elmhurst | Illinois | 60126 | — |
| Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0066) | Naperville | Illinois | 60540 | — |
| Edward-Elmhurst Healthcare, Edward Hospital - Plainfield-Edward Cancer Center - Plainfield ( Site 00 | Plainfield | Illinois | 60585 | — |
| Orchard Healthcare Research Inc. ( Site 0037) | Skokie | Illinois | 60077 | — |
| Parkview Research Center at Parkview Regional Medical Center ( Site 0071) | Fort Wayne | Indiana | 46845 | — |
| McFarland Clinic, PC ( Site 0041) | Ames | Iowa | 50010-3014 | — |
| Louisiana State University Health Sciences Shreveport ( Site 0072) | Shreveport | Louisiana | 71103 | — |
| CHRISTUS Highland-Oncology Research ( Site 0073) | Shreveport | Louisiana | 71105 | — |
| New England Cancer Specialists ( Site 0007) | Scarborough | Maine | 04074 | — |
| Greater Baltimore Medical Center-Medical Oncology/Hematology ( Site 0062) | Baltimore | Maryland | 21204 | — |
| MFSMC-HJWCI ( Site 0064) | Baltimore | Maryland | 21237 | — |
| MedStar Good Samaritan Hospital-Oncology Research ( Site 0069) | Baltimore | Maryland | 21239 | — |
| University of Massachusetts Medical School-Division of Hematology/Oncology ( Site 0052) | Worcester | Massachusetts | 01655 | — |
| Henry Ford Hospital ( Site 0003) | Detroit | Michigan | 48202 | — |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0009) | Omaha | Nebraska | 68130 | — |
| Broome Oncology ( Site 0018) | Johnson City | New York | 13790 | — |
| Hematology Oncology Associates of Rockland ( Site 0044) | Nyack | New York | 10960 | — |
| Waverly Hematology Oncology ( Site 0015) | Cary | North Carolina | 27518 | — |
| Sanford Fargo Medical Center ( Site 0040) | Fargo | North Dakota | 58102 | — |
| Providence Portland Medical Center ( Site 0038) | Portland | Oregon | 97213 | — |
| Oregon Health and Science University ( Site 0031) | Portland | Oregon | 97239-3011 | — |
| St Francis Cancer Center ( Site 0058) | Greenville | South Carolina | 29607 | — |
| Sanford Cancer Center ( Site 0021) | Sioux Falls | South Dakota | 57104 | — |
| University of Tennessee Medical Center ( Site 0039) | Knoxville | Tennessee | 37920 | — |
| Bon Secours St. Francis Medical Center-Oncology Research ( Site 0020) | Midlothian | Virginia | 23114 | — |
| Kadlec Clinic Hematology and Oncology ( Site 0055) | Kennewick | Washington | 99336 | — |
| Medical Oncology Associates, PS ( Site 0010) | Spokane | Washington | 99208 | — |
| Northwest Medical Specialties, PLLC ( Site 0008) | Tacoma | Washington | 98405 | — |
| North Star Lodge ( Site 0035) | Yakima | Washington | 98902 | — |
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 215 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04895358, 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 22, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04895358 live on ClinicalTrials.gov.