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NCT02957968 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca
A Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer, sponsored by Virginia Commonwealth University.
- Active
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 4
- Study locations
NCT02957968 is a Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer that is active but no longer recruiting, run by Virginia Commonwealth University. The registered enrollment target is 46 participants, below the 484-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT02957968, a Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer, is active but no longer recruiting, sponsored by Virginia Commonwealth University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study is a 2-cohort, open-label, multicenter, phase 2 study of a short course of immunotherapy consisting of sequential decitabine followed by pembrolizumab administered prior to a standard neoadjuvant chemotherapy regimen for patients with locally advanced HER2-negative breast cancer. The primary efficacy objective is to determine if the immunotherapy increases the presence and percentage of tumor and/or stromal area of infiltrating lymphocytes prior to initiation of standard neoadjuvant chemotherapy. At enrollment, patients will be assigned to one of 2 cohorts based on hormone receptor status. * Cohort A - patients with HER2-negative, hormone receptor-negative breast cancer (defined as both ER and PgR with \< 10% positive staining on IHC) Note: before beginning standard neoadjuvant chemotherapy, patients in Cohort A may be reassigned to Cohort A2 to receive extended pembrolizumab as part of new standard neoadjuvant and postoperative adjuvant therapy. * Cohort B - patients with HER2-negative, hormone receptor-positive breast cancer (defined as either ER or PgR with ≥ 10% positive staining on IHC)
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Carboplatin
- DRUG Doxorubicin
- DRUG Decitabine
- DRUG Paclitaxel
Study Locations (4)
Virginia
- University of Virginia - Charlottesville
- Virginia Commonwealth University/Massey Cancer Center - Richmond
Kentucky
- St. Elizabeth Healthcare - Edgewood
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2017-01-24 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02957968
The ClinicalTrials.gov registry entry for NCT02957968 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 484-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (90% lower). The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Invasive Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02957968 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Virginia, Kentucky, Ohio.
Frequently Asked Questions
What is clinical trial NCT02957968 about?
NCT02957968 is a clinical study titled "Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca". This study is a 2-cohort, open-label, multicenter, phase 2 study of a short course of immunotherapy consisting of sequential decitabine followed by pembrolizumab administered prior to a standard neoadjuvant chemotherapy regimen for patients with locally advanced HER2-negative breast cancer. The prim...
What is the current status of trial NCT02957968?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2017-01-24. Estimated completion is 2026-03-31.
What conditions does trial NCT02957968 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, Stage II Breast Cancer, HER2/Neu Negative, Breast Adenocarcinoma, Progesterone Receptor Negative.
What interventions are being tested in trial NCT02957968?
The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Doxorubicin (DRUG), Decitabine (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT02957968?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02957968 being conducted?
This trial has 4 study locations across Kentucky, Ohio, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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