Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer
Public ClinicalTrials.gov record NCT03012100. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03012100
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 280 participants
Conditions and interventions
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
Interventions
- Cyclophosphamide Drug
- Laboratory Biomarker Analysis Other
- Multi-epitope Folate Receptor Alpha Peptide Vaccine Biological
- Placebo Administration Other
- Sargramostim Biological
Drug · Other · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2017 (Actual)
- Primary completion
- Feb 28, 2025 (Actual)
- Completion
- Jul 31, 2026 (Estimated)
- Last update posted
- Jun 30, 2026
2017 – 2026
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | — |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Carle Cancer Center NCI Community Oncology Research Program | Urbana | Illinois | 61801 | — |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | — |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03012100, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 30, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03012100 live on ClinicalTrials.gov.