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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 0 → 1 primary endpoints
See other at-risk trials from Academic and Community Cancer Research United

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified
    • Results first posted: Jun 30, 2026
    v43
  2. Primary completion date: Aug 30, 2022 to Feb 28, 2025
    • Secondary endpoints: 4 to 2
    • Primary endpoint revised
    v42
  3. Eligibility criteria expanded, about 46 wordsv41
  4. Primary completion date changed from estimate of Jul 31, 2023 to Aug 30, 2022v40
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 12 of 12 sites
    v39
Show 37 earlier versionsHide 37 earlier versions
  1. Primary completion date: Jul 31, 2021 to Jul 31, 2023v38
  2. Site contacts updated at 1 of 12 sitesv37
  3. Study sites: 13 to 12v36
  4. Study completion date: Jul 31, 2024 to Jul 31, 2026v35 Show 4 more changesShow less
    • Interventions: Cyclophosphamide (Drug), Laboratory Biomarker Analysis (Other), Multi-epitope Folate Receptor Alpha Peptide Vaccine (Biological), Placebo… to Cyclophosphamide (Drug), Laboratory Biomarker Analysis (Other), Multi-epitope Folate Receptor Alpha Peptide Vaccine (Biological), Placebo…
    • Eligibility criteria shortened, about 42 words
    • Study description revised
    • Study sites revised (13)
  5. Site contacts updated at 1 of 13 sitesv34
  6. Re-verified, no change to tracked fieldsv33
  7. Site contacts updated at 1 of 13 sitesv32
  8. Re-verified, no change to tracked fieldsv31
  9. Site contacts updated at 1 of 13 sitesv30
  10. Site contacts updated at 1 of 13 sitesv29
  11. Site contacts updated at 1 of 13 sitesv28
  12. Site details revised at 1 of 13 sitesv27
  13. Site contacts updated at 1 of 13 sitesv26
  14. Site contacts updated at 4 of 13 sitesv25
  15. Study completion date: Jul 31, 2026 to Jul 31, 2024
    • Site contacts updated at 4 of 13 sites
    • Study title revised
    • Eligibility criteria shortened, about 1 word
    v24
  16. Site contacts updated at 3 of 13 sitesv23
  17. Site contacts updated at 1 of 13 sitesv22
  18. Study completion date: Jul 31, 2022 to Jul 31, 2026
    • Site contacts updated at 1 of 13 sites
    v21
  19. Site contacts updated at 1 of 13 sitesv20
  20. Study completion date: Jul 31, 2023 to Jul 31, 2022
    • Eligibility criteria shortened, about 25 words
    • Site details revised at 2 of 13 sites
    • Study description expanded, about 1 word
    v19
  21. Site contacts updated at 1 of 13 sitesv18
  22. Study sites: 11 to 13v17
  23. Site contacts updated at 3 of 11 sitesv16
  24. Study completion date: Jul 31, 2021 to Jul 31, 2023
    • Eligibility criteria expanded, about 247 words
    • Secondary endpoints revised (4)
    • Study sites revised (11)
    v15
  25. Site details revised at 1 of 11 sitesv14
  26. Site details revised at 1 of 11 sitesv13
  27. Site details revised at 1 of 11 sitesv12
  28. Study sites revised (11)v11
  29. Site details revised at 2 of 11 sitesv10
  30. Site details revised at 2 of 11 sitesv9
  31. Site contacts updated at 3 of 11 sitesv8
  32. Site details revised at 1 of 11 sitesv7
  33. Site details revised at 1 of 11 sitesv6
  34. Trial status: Active, Not Recruiting to Recruitingv5 Show 4 more changesShow less
    • Study sites: 10 to 11
    • Primary completion date: Jul 2021 to Jul 31, 2021
    • Study completion date: Dec 2021 to Jul 31, 2021
    • Eligibility criteria revised
  35. Study completion date: Dec 2021v4
  36. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Mar 2017 to Mar 31, 2017
    • Site details revised at 10 of 10 sites
    • Study description shortened, about 4 words
    v3
  37. Start date: Jan 2017 to Mar 2017v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03012100
Lead Sponsor Academic and Community Cancer Research United
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 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 +4 more
Related terms Breast Neoplasms, Inflammatory Breast Neoplasms, Triple Negative Breast Neoplasms, Unilateral Breast Neoplasms
Enrollment 280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov