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NCT02954874 · ClinicalTrials.gov registry record · Phase 3
Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer
A Phase 3 study of Invasive Breast Carcinoma and Triple-Negative Breast Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 1,155
- Enrollment target
- 20
- Study locations
NCT02954874: Active Phase 3 study of Invasive Breast Carcinoma and Triple-Negative Breast Carcinoma, sponsored by National Cancer Institute (NCI).
NCT02954874 is a Phase 3 study of Invasive Breast Carcinoma and Triple-Negative Breast Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 1,155 participants, above the 459-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (152% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02954874, a Phase 3 study of Invasive Breast Carcinoma and Triple-Negative Breast Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,155 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
The distributions of IDFS will be estimated using the Kaplan-Meier method, with 95% confidence intervals (CI) calculated using Greenwood's formula. Comparisons between the two treatment arms will be performed using the stratified log-rank test. The hazard ratios and 95% CIs will be based on the stratified Cox proportional hazard model with treatment as the only covariate. Secondary analyses of IDFS will be performed to describe consistency or divergence across subgroups. This will include a fore
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- OTHER Patient Observation
Study Locations (20)
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- Southern Cancer Center PC-Daphne - Daphne
- Southern Cancer Center PC-Mobile - Mobile
- Southern Cancer Center PC-Providence - Mobile
- Southern Cancer Center PC-Springhill - Mobile
- University of South Alabama Mitchell Cancer Institute - Mobile
Alaska
- Alaska Oncology and Hematology LLC - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- CTCA at Western Regional Medical Center - Goodyear
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- University of Arkansas for Medical Sciences - Little Rock
- Highlands Oncology Group - Rogers - Rogers
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Deer Valley Medical Center - Antioch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,155 participants |
| Start Date | 2017-01-18 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 3 |
What the registry record for NCT02954874 still lists
NCT02954874 is an interventional study that assigns participants to a tested intervention. Its 1,155 participants enrollment target places it among the larger protocols in the corpus, above the 459-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (152% higher).
The record links to 6 conditions, with Invasive Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT02954874 names 20 study sites across 5 states, led by Alabama, Alaska, Arizona.
Frequently Asked Questions
What is clinical trial NCT02954874 about?
NCT02954874 is a clinical study titled "Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer". This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to gro...
What is the current status of trial NCT02954874?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,155 participants. The study started on 2017-01-18. Estimated completion is 2026-05-31.
What conditions does trial NCT02954874 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, Triple-Negative Breast Carcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage I Breast Cancer AJCC v7.
What interventions are being tested in trial NCT02954874?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Patient Observation (OTHER).
Who is sponsoring clinical trial NCT02954874?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02954874 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Invasive Breast Carcinoma
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 NCT02954874's enrollment target sits among peer trials
1,155 7th of 45 higher than 39 of 45 other Invasive Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Invasive Breast Carcinoma 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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