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NCT03725059 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Breast Cancer, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 1,240
- Enrollment target
- 20
- Study locations
NCT03725059: Active Phase 3 study of Breast Cancer, sponsored by Merck Sharp & Dohme.
NCT03725059 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 1,240 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03725059, a Phase 3 study of Breast Cancer, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,240 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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 definit
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab (K)
- DRUG Placebo (P)
- DRUG Paclitaxel (X)
- DRUG Doxorubicin (A)
- DRUG Epirubicin (E)
Study Locations (20)
California
- Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079) - Los Angeles
- El Camino Hospital Cancer Center ( Site 0004) - Mountain View
- Stanford Cancer Center ( Site 0072) - Palo Alto
- UC Davis Comprehensive Cancer Center ( Site 0073) - Sacramento
Illinois
- The University of Chicago Medical Center ( Site 0080) - Chicago
- Orchard Healthcare Research Inc. ( Site 0020) - Skokie
- Midwestern Regional Medical Center, Inc. ( Site 0077) - Zion
Massachusetts
- Massachusetts General Hospital ( Site 0024) - Boston
- MGH - North Shore Cancer Center ( Site 0081) - Danvers
- MGH Newton-Wellesley Hospital's Vernon Cancer Center ( Site 0082) - Newton
Arizona
- Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001) - Goodyear
- Arizona Oncology Associates PC- HOPE ( Site 8008) - Tucson
Alabama
- Southern Cancer Center, PC ( Site 8003) - Daphne
Colorado
- University of Colorado, Anschutz Cancer Pavilion ( Site 0008) - Aurora
Florida
- Baptist MD Anderson Cancer Center ( Site 0014) - Jacksonville
Georgia
- Southeastern Regional Medical Center, Inc. ( Site 0075) - Newnan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,240 participants |
| Start Date | 2018-12-27 |
| Est. Completion | 2031-01-24 |
| Phase | Phase 3 |
What the registry record for NCT03725059 still lists
NCT03725059 is an interventional study that assigns participants to a tested intervention. Its 1,240 participants enrollment target places it among the larger protocols in the corpus, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab (K) is the first listed.
NCT03725059 names 20 study sites across 12 states, led by California, Illinois, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03725059 about?
NCT03725059 is a clinical study titled "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)". 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, huma...
What is the current status of trial NCT03725059?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,240 participants. The study started on 2018-12-27. Estimated completion is 2031-01-24.
What conditions does trial NCT03725059 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03725059?
The interventions under investigation include: Pembrolizumab (K) (BIOLOGICAL), Placebo (P) (DRUG), Paclitaxel (X) (DRUG), Doxorubicin (A) (DRUG), Epirubicin (E) (DRUG).
Who is sponsoring clinical trial NCT03725059?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03725059 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03725059's enrollment target sits among peer trials
1,240 100th of 1224 higher than 1,125 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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