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NCT03012100 · ClinicalTrials.gov registry record · Phase 2
Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer
A Phase 2 study of Stage II Breast Cancer AJCC v6 and v7 and Stage IIA Breast Cancer AJCC v6 and v7, sponsored by Academic and Community Cancer Research United.
- Active
- Registry status
- Phase 2
- Development phase
- 280
- Enrollment target
- 12
- Study locations
NCT03012100 is a Phase 2 study of Stage II Breast Cancer AJCC v6 and v7 and Stage IIA Breast Cancer AJCC v6 and v7 that is active but no longer recruiting, run by Academic and Community Cancer Research United. The registered enrollment target is 280 participants, below the 338-participant average among 11 other Stage II Breast Cancer AJCC v6 and v7 trials with a reported enrollment target (17% lower). The trial reports 12 study locations across 9 states.
The verdict
NCT03012100, a Phase 2 study of Stage II Breast Cancer AJCC v6 and v7 and Stage IIA Breast Cancer AJCC v6 and v7, is active but no longer recruiting, sponsored by Academic and Community Cancer Research United.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 280 participants
- Enrollment target
- 12
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2017-03-31 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 338-participant average among 11 other Stage II Breast Cancer AJCC v6 and v7 trials with a reported enrollment target (17% lower). The listed sponsor is Academic and Community Cancer Research United, which has 42 total studies on file at ClinicalTrials.gov.
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.
NCT03012100 reports 12 study locations spanning 9 distinct geographic areas - top geographies include Florida, Illinois, Massachusetts.
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.
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).
Who is sponsoring clinical trial NCT03012100?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
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.
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