OncRef

Clinical Trial: NCT03012100

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Academic and Community Cancer Research United
Information Provided By:Academic and Community Cancer Research United
Last Update Posted:2026-06-30

Study Overview

Brief Summary

This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide work to prevent the recurrence of stage 1-3 triple negative breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide may work well together to prevent cancer recurrence after surgery and other standard treatments for triple negative breast cancer.

Official Title

Double Blind, Parallel Groups, Controlled, Randomized Phase II Trial to Evaluate Vaccination With Folate Receptor Alpha Peptide Vaccine With GM-CSF as Vaccine Adjuvant Following Oral Cyclophosphamide Versus GM-CSF/Placebo to Prevent Recurrence in Patients With Triple Negative Breast Cancer

Conditions

Bilateral Breast Carcinoma, Breast Inflammatory Carcinoma, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Triple-Negative Breast Carcinoma, Unilateral Breast Carcinoma

Intervention / Treatment

  • Drug: Cyclophosphamide
  • Other: Laboratory Biomarker Analysis
  • Biological: Multi-epitope Folate Receptor Alpha Peptide Vaccine
  • Other: Placebo Administration
  • Biological: Sargramostim

Other Study ID Numbers

  • RU011501I
  • NCI-2016-01878
  • RU011501I
  • P30CA015083

Start Date (Actual)

2017-03-31

Primary Completion Date (Actual)

2025-02-28

Study Completion Date (Estimated)

2026-07-31

Enrollment (Actual)

280

Study Type

Interventional

Phase

Phase 2