NCT03012100View on ClinicalTrials.gov

Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

March 31, 2017

Primary Completion Date

August 30, 2022

Study Completion Date

July 31, 2026

Conditions
Bilateral Breast CarcinomaBreast Inflammatory CarcinomaStage IB Breast Cancer AJCC v7Stage II Breast Cancer AJCC v6 and v7Stage IIA Breast Cancer AJCC v6 and v7Stage IIB Breast Cancer AJCC v6 and v7Stage III Breast Cancer AJCC v7Stage IIIA Breast Cancer AJCC v7Stage IIIB Breast Cancer AJCC v7Stage IIIC Breast Cancer AJCC v7Triple-Negative Breast CarcinomaUnilateral Breast Carcinoma
Interventions
DRUG

Cyclophosphamide

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Multi-epitope Folate Receptor Alpha Peptide Vaccine

Given ID

OTHER

Placebo Administration

Given ID

BIOLOGICAL

Sargramostim

Given ID

Trial Locations (12)

22042

Inova Fairfax Hospital, Falls Church

33136

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami

54449

Marshfield Medical Center-Marshfield, Marshfield

55905

Mayo Clinic in Rochester, Rochester

60637

University of Chicago Comprehensive Cancer Center, Chicago

61801

Carle Cancer Center NCI Community Oncology Research Program, Urbana

70121

Ochsner Medical Center Jefferson, New Orleans

85259

Mayo Clinic in Arizona, Scottsdale

91010

City of Hope Comprehensive Cancer Center, Duarte

32224-9980

Mayo Clinic in Florida, Jacksonville

02114

Massachusetts General Hospital Cancer Center, Boston

02215

Dana-Farber Cancer Institute, Boston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Academic and Community Cancer Research United

OTHER