Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)
Public ClinicalTrials.gov record NCT03036488. 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 Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC). After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence. The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.
Study identification
- NCT ID
- NCT03036488
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,174 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Carboplatin Drug
- Paclitaxel Drug
- Doxorubicin Drug
- Epirubicin Drug
- Cyclophosphamide Drug
- Placebo Drug
- Granulocyte colony stimulating factor: Filgrastim or Pegfilgastrim Biological
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
- Mar 7, 2017 (Actual)
- Primary completion
- Oct 14, 2025 (Actual)
- Completion
- Oct 14, 2025 (Actual)
- Last update posted
- Oct 29, 2025
2017 – 2025
United States locations
- U.S. sites
- 47
- U.S. states
- 22
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Virginia G. Piper Cancer Center Pharmacy - Scottsdale Healthcare ( Site 0089) | Scottsdale | Arizona | 85268 | — |
| Arizona Oncology Associates PC- HOPE ( Site 8001) | Tucson | Arizona | 85711 | — |
| Cedars Sinai Medical Center ( Site 0091) | Los Angeles | California | 90048 | — |
| Pacific Cancer Care ( Site 0069) | Monterey | California | 93940 | — |
| ICRI ( Site 0072) | Whittier | California | 90603 | — |
| University of Colorado Cancer Center ( Site 0021) | Aurora | Colorado | 80045 | — |
| Yale University School of Medicine ( Site 0054) | New Haven | Connecticut | 06510 | — |
| Christiana Hospital ( Site 0029) | Newark | Delaware | 19713 | — |
| Univ of Miami-Sylvester Comprehensive Cancer Center- Kendall satellite ( Site 0079) | Miami | Florida | 33176 | — |
| The University of Chicago Medical Center ( Site 0047) | Chicago | Illinois | 60637-1447 | — |
| North Shore University Health System ( Site 0081) | Evanston | Illinois | 60201 | — |
| Orchard Healthcare Research Inc. ( Site 0049) | Skokie | Illinois | 60077 | — |
| Goshen Center for Cancer Care ( Site 0010) | Goshen | Indiana | 46526 | — |
| University of Iowa Hospital and Clinics ( Site 0038) | Iowa City | Iowa | 52242 | — |
| New England Cancer Specialists ( Site 0005) | Scarborough | Maine | 04074 | — |
| Henry Ford Hospital ( Site 0003) | Detroit | Michigan | 48202 | — |
| Minnesota Oncology Hematology, PA ( Site 8013) | Minneapolis | Minnesota | 55404 | — |
| Rutgers Cancer Institute of New Jersey ( Site 0073) | New Brunswick | New Jersey | 08903 | — |
| Broome Oncology, LLC ( Site 8002) | Johnson City | New York | 13790 | — |
| Nyack Hospital Infusion Center ( Site 0059) | Nyack | New York | 10960 | — |
| TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0044) | Cincinnati | Ohio | 45220 | — |
| Oncology Hematology Care, Inc. ( Site 8011) | Cincinnati | Ohio | 45242 | — |
| Providence Portland Medical Center ( Site 0052) | Portland | Oregon | 97213 | — |
| Northwest Cancer Specialists, P.C. ( Site 8008) | Portland | Oregon | 97227 | — |
| Magee - Women's Hospital ( Site 0011) | Pittsburgh | Pennsylvania | 15213 | — |
| Rhode Island Hospital ( Site 0060) | Providence | Rhode Island | 02903 | — |
| The West Clinic, P.C. ( Site 0078) | Germantown | Tennessee | 38138 | — |
| Texas Oncology-Austin Central ( Site 8005) | Austin | Texas | 78731 | — |
| Parkland Health and Hospital System ( Site 0093) | Dallas | Texas | 75235 | — |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8006) | Dallas | Texas | 75246 | — |
| Simmons Cancer Center ( Site 0094) | Dallas | Texas | 75390-9015 | — |
| UT Southwestern Medical Center ( Site 0030) | Dallas | Texas | 75390-9179 | — |
| Moncrief Cancer Institute ( Site 0092) | Fort Worth | Texas | 76104 | — |
| Texas Oncology-Memorial City ( Site 8003) | Houston | Texas | 77024 | — |
| Houston Methodist Cancer Center ( Site 0013) | Houston | Texas | 77030 | — |
| Texas Oncology- Plano East ( Site 8010) | Plano | Texas | 75075 | — |
| Texas Oncology-San Antonio Northeast ( Site 8012) | San Antonio | Texas | 78217 | — |
| Texas Oncology-Tyler ( Site 8007) | Tyler | Texas | 75702 | — |
| University of Virginia ( Site 0022) | Charlottesville | Virginia | 22903 | — |
| Virginia Cancer Specialists, PC ( Site 8009) | Fairfax | Virginia | 22031 | — |
| Bon Secours Cancer Institute Medical Oncology at St. Mary's ( Site 0033) | Midlothian | Virginia | 23114 | — |
| Peninsula Cancer Institute, LLC ( Site 0041) | Newport News | Virginia | 23601 | — |
| Virginia Oncology Associates ( Site 8000) | Norfolk | Virginia | 23502 | — |
| Kadlec Clinic Hematology and Oncology ( Site 0087) | Kennewick | Washington | 99336 | — |
| Seattle Cancer Care Alliance ( Site 0068) | Seattle | Washington | 98109 | — |
| Medical Oncology Associates (Summit Cancer Centers) ( Site 0014) | Spokane | Washington | 99208 | — |
| YVMH dba Vrigina Mason Memorial/North Star Lodge Cancer Center ( Site 8004) | 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 146 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03036488, 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 Oct 29, 2025 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03036488 live on ClinicalTrials.gov.