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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: Active Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer, sponsored by Virginia Commonwealth University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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)

Primary Outcome

To determine and quantify if treatment with neoadjuvant decitabine followed by pembrolizumab increases lymphocyte infiltration into tumor and/or stroma in patients with locally advanced, HER2-negative breast cancer.

Conditions Studied

Invasive Breast Carcinoma Stage II Breast Cancer HER2/Neu Negative Breast Adenocarcinoma Progesterone Receptor Negative Stage IIA Breast Cancer Estrogen Receptor-positive Breast Cancer Stage IIB Breast Cancer Estrogen Receptor-negative Breast Cancer Progesterone Receptor Positive Tumor

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

FieldValue
Enrollment Target 46 participants
Start Date 2017-01-24
Est. Completion 2026-03-31
Phase Phase 2
Virginia Commonwealth University

558 total trials

What the registry record for NCT02957968 still lists

NCT02957968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 484-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (90% lower).

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 a single indexed study location in 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.

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 NCT02957968's enrollment target sits among peer trials

46 35th of 45 higher than 11 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02957968, the US trial registry maintained by the National Library of Medicine. NCT02957968 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.