Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca
Public ClinicalTrials.gov record NCT02957968. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
T-Cell Immune Checkpoint Inhibition Plus Hypomethylation for Locally Advanced HER2-Negative Breast Cancer - A Phase 2 Neoadjuvant Window Trial of Pembrolizumab and Decitabine Followed by Standard Neoadjuvant Chemotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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)
Study identification
- NCT ID
- NCT02957968
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 46 participants
Conditions and interventions
Conditions
- Breast Adenocarcinoma
- Estrogen Receptor- Negative Breast Cancer
- Estrogen Receptor-positive Breast Cancer
- HER2/Neu Negative
- Invasive Breast Carcinoma
- Progesterone Receptor Negative
- Progesterone Receptor Positive Tumor
- Stage II Breast Cancer
- Stage IIA Breast Cancer
- Stage IIB Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Triple-negative Breast Carcinoma
Interventions
- Doxorubicin Drug
- Cyclophosphamide Drug
- Paclitaxel Drug
- Carboplatin Drug
- Decitabine Drug
- Pembrolizumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 23, 2017
- Primary completion
- Aug 3, 2022
- Completion
- Mar 30, 2027
- Last update posted
- Jun 30, 2026
2017 – 2027
United States locations
- U.S. sites
- 4
- U.S. states
- 3
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Elizabeth Healthcare | Edgewood | Kentucky | 41017 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02957968, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 30, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02957968 live on ClinicalTrials.gov.