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NCT05812807 · ClinicalTrials.gov registry record · Phase 3
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
A Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by Alliance for Clinical Trials in Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,295
- Enrollment target
- 20
- Study locations
NCT05812807 is a Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that is actively recruiting participants, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 1,295 participants, above the 289-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (348% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT05812807, a Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, is actively recruiting participants, sponsored by Alliance for Clinical Trials in Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,295 participants
- Enrollment target
- 20
- Study locations
Study Summary
The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. 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. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy
- OTHER Questionnaire Administration
- OTHER Patient Observation
Study Locations (20)
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Tower Cancer Research Foundation - Beverly Hills
- Marshall Cancer Center - Cameron Park
- Mercy Cancer Center - Carmichael - Carmichael
Arkansas
- Highlands Oncology Group - Fayetteville - Fayetteville
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- University of Arkansas for Medical Sciences - Little Rock
- Highlands Oncology Group - Rogers - Rogers
- Highlands Oncology Group - Springdale
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- Thomas Hospital - Fairhope
- Mobile Infirmary Medical Center - Mobile
- University of South Alabama Mitchell Cancer Institute - Mobile
Arizona
- CTCA at Western Regional Medical Center - Goodyear
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
Alaska
- Katmai Oncology Group - Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,295 participants |
| Start Date | 2023-06-14 |
| Est. Completion | 2033-05-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05812807
The ClinicalTrials.gov registry entry for NCT05812807 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,295 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 289-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (348% higher). The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05812807 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arkansas, Alabama.
Frequently Asked Questions
What is clinical trial NCT05812807 about?
NCT05812807 is a clinical study titled "Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab". The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies...
What is the current status of trial NCT05812807?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,295 participants. The study started on 2023-06-14. Estimated completion is 2033-05-31.
What conditions does trial NCT05812807 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Early Stage Triple-Negative Breast Carcinoma.
What interventions are being tested in trial NCT05812807?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Biopsy (PROCEDURE), Questionnaire Administration (OTHER), Patient Observation (OTHER).
Who is sponsoring clinical trial NCT05812807?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05812807 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.
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Anatomic Stage III Breast Cancer AJCC v8
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Anatomic Stage II Breast Cancer AJCC v8
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Alabama
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.