NCT02957968View on ClinicalTrials.gov

Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

January 24, 2017

Primary Completion Date

August 4, 2022

Study Completion Date

March 31, 2026

Conditions
Breast AdenocarcinomaEstrogen Receptor- Negative Breast CancerEstrogen Receptor-positive Breast CancerHER2/Neu NegativeInvasive Breast CarcinomaProgesterone Receptor NegativeProgesterone Receptor Positive TumorStage II Breast CancerStage IIA Breast CancerStage IIB Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerTriple-negative Breast Carcinoma
Interventions
DRUG

Doxorubicin

60 mg/m2 once every 2 weeks for 4 cycles.

DRUG

Cyclophosphamide

cyclophosphamide 600 mg/m2 (AC) once every 2 weeks for 4 cycles.

DRUG

Paclitaxel

Paclitaxel 80 mg/m2 IV once weekly for 12 weeks.

DRUG

Carboplatin

carboplatin IV 1.5 area under curve (AUC) once weekly for 12 weeks.

DRUG

Decitabine

Given IV

DRUG

Pembrolizumab

Given IV

Trial Locations (4)

22903

University of Virginia, Charlottesville

23298

Virginia Commonwealth University/Massey Cancer Center, Richmond

41017

St. Elizabeth Healthcare, Edgewood

43210

Ohio State University Comprehensive Cancer Center, Columbus

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

Virginia Commonwealth University

OTHER