Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active 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.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be estimated using the method of Kaplan-Meier. Will use the stratified log-rank tests.
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 |
What the registry record for NCT03012100 still lists
NCT03012100 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, 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 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 lists 12 locations in 9 states (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.
Learn More About Clinical Trials
Similar trials for Stage II Breast Cancer AJCC v6 and v7
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03012100's enrollment target sits among peer trials
280 5th of 11 higher than 7 of 11 other Stage II Breast Cancer AJCC v6 and v7 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage II Breast Cancer AJCC v6 and v7 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer
ACTIVE NOT RECRUITING · Phase 2
-
Hypofractionated vs. Conventional Regional Nodal Radiation Therapy for Patients With Invasive Breast Cancer
ACTIVE NOT RECRUITING · Phase 2
-
Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer
ACTIVE NOT RECRUITING · Phase 2
-
Electroacupuncture Therapy in Reducing Chronic Pain in Patients After Breast Cancer Treatment
ACTIVE NOT RECRUITING · Phase 2
-
Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer
ACTIVE NOT RECRUITING · Phase 2
-
Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04084730 · 280 participants · Phase 2
Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer
- NCT04518657 · 280 participants · NA
Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis
- NCT04634916 · 280 participants · NA
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
- NCT04829617 · 280 participants · NA
Promoting Well-being and Health in Heart Failure
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI