Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

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

NCT03012100 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Cyclophosphamide
  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Sargramostim
  • OTHER Placebo Administration
  • BIOLOGICAL Multi-epitope Folate Receptor Alpha Peptide Vaccine

Study Locations (12)

Florida

  • Mayo Clinic in Florida — Jacksonville
  • University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami

Illinois

  • University of Chicago Comprehensive Cancer Center — Chicago
  • Carle Cancer Center NCI Community Oncology Research Program — Urbana

Massachusetts

  • Massachusetts General Hospital Cancer Center — Boston
  • Dana-Farber Cancer Institute — Boston

Arizona

  • Mayo Clinic in Arizona — Scottsdale

California

  • City of Hope Comprehensive Cancer Center — Duarte

Louisiana

  • Ochsner Medical Center Jefferson — New Orleans

Minnesota

  • Mayo Clinic in Rochester — Rochester

Virginia

  • Inova Fairfax Hospital — Falls Church

Trial Details

FieldValue
Enrollment Target 280 participants
Start Date 2017-03-31
Est. Completion 2026-07-31
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03012100

The ClinicalTrials.gov registry entry for NCT03012100 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Academic and Community Cancer Research United, which has 21 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Stage II Breast Cancer AJCC v6 and v7 appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03012100 reports 12 study locations spanning 9 distinct geographic areas — top geographies include Florida, Illinois, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03012100 about?

NCT03012100 is a clinical study titled "Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer". 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 he...

What is the current status of trial NCT03012100?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 280 participants. The study started on 2017-03-31. Estimated completion is 2026-07-31.

What conditions does trial NCT03012100 study?

This clinical trial studies the following conditions: Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03012100?

The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Sargramostim (BIOLOGICAL), Placebo Administration (OTHER), Multi-epitope Folate Receptor Alpha Peptide Vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03012100?

This trial is sponsored by Academic and Community Cancer Research United, which has 21 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03012100 being conducted?

This trial has 12 study locations across Arizona, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial