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
Study identification
- NCT ID
- NCT03012100
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Academic and Community Cancer Research United
- Other
- 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 30, 2017
- Primary completion
- Aug 29, 2022
- Completion
- Jul 30, 2026
- Last update posted
- Jan 12, 2023
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 Jan 12, 2023 · Synced May 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03012100 live on ClinicalTrials.gov.