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Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
NCT05812807 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,295 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05812807 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Arkansas, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05812807?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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