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

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 17-003039
    • Scottsdale/Phoenix, Arizona: 17-003039
    • Jacksonville, Florida: 17-003039
    NCT ID: NCT03012100
    Sponsor Protocol Number: RU011501I

About this study

The purpose of this study is to evaluate how well multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide work in treating patients with 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, and cyclophosphamide may work better in treating patients with triple negative breast cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Resected unilateral or bilateral primary carcinoma of the breast without clinical evidence of metastatic disease (after neoadjuvant chemotherapy and/or adjuvant chemotherapy), negative for estrogen receptor (ER) and progesterone receptor (PR) (cut-off for positivity is > 10% positive tumor cells with nuclear staining), and negative for HER2 as defined by one of the four situations delineated below: 
    • HER2 immunohistochemistry (IHC) expression of 0 or 1+ and in-situ hybridization non-amplified;
    • HER2 IHC expression of 0 or 1+ and in-situ hybridization not done;
    • HER2 IHC expression of 2+ and in-situ hybridization non-amplified; 
    • IHC not done and in-situ hybridization non-amplified. 
      • Note: central review is not required. 
      • Note: If biopsy and surgical specimens are discordant from each other with regard to ER, PR, and/or HER2 status, a patient will be allowed to enroll assuming at least one of the specimens meets the above criteria and no endocrine therapy use is planned going forward.
  • Completed planned breast surgeries and any radiation therapy ≥ 60 days prior to randomization. 
    • Note: Reconstructive and prophylactic surgeries are allowed after randomization (during study treatment).
  • Completed last cycle of chemotherapy (which can be given in the adjuvant and/or neoadjuvant setting) ≥ 90 days but not ≥ 365 days prior to randomization. 
  • Patient had at least one of the following: 
    • Biopsy or surgery-proven regional node involvement by cancer;
    • T1c, T2, T3, or T4 (disease with inflammatory disease allowed) identified at the time of surgery or clinically identified prior to neoadjuvant chemotherapy);
    • No complete response to neoadjuvant chemotherapy (those who did achieve complete response are still eligible if a pre-chemotherapy regional nodal biopsy identified cancer or if the pre-chemotherapy tumor measured > 1 cm).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1.
  • Absolute neutrophil count (ANC) ≥ 1500/mm^3 obtained ≤ 14 days prior to randomization.
  • Platelet count ≥ 75,000/uL obtained ≤ 14 days prior to randomization.
  • Aspartate transaminase (AST) ≤ 3 x upper limit of normal (ULN) obtained ≤ 14 days prior to randomization. 
  • Creatinine ≤ 1.5 x ULN obtained ≤ 14 days prior to randomization.
  • Urine dipstick proteinuria < 2+ or urine protein/creatinine (UPC) ratio ≤ 1.0 obtained ≤ 14 days prior to randomization.
    • Note: patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤ 1 g of protein in 24 hours. 
  • Negative serum pregnancy test done ≤ 14 days prior to randomization, for women of childbearing potential only. 
  • Provide informed written consent.
  • Willing to return to enrolling institution for follow-up.
  • Willing to provide tissue and blood samples for correlative research studies.

Exclusion Criteria: 

  • Pregnant women. 
  • Nursing women.
  • Women of childbearing potential who are unwilling to employ adequate contraception.
  • Clinical evidence of local recurrence or distant metastases.
    • Note: New primary tumors are allowed, both contralaterally and ipsilaterally, but a prior breast cancer must have been more than 5 years beforehand 
  • Known hypersensitivity reaction to GM-CSF.
  • Active autoimmune disease that has required systemic treatment ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to randomization.
    • Note: replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment; patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded; patients with Celiac disease controlled with diet modification are not excluded.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • History of other cancer < 5 years prior to consent (except non-melanoma skin cancer or carcinoma in situ of the uterine cervix) or receiving other specific treatment for this cancer (monoclonal antibody, small molecule pathway inhibitor).
  • Treatment with systemic corticosteroid or immune-modulators ≤ 7 days prior to randomization. 
  • Concurrent treatment with other experimental drugs or any other systemic anticancer therapy (due to unknown drug-vaccine potential interactions).
    • NOTE: Aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), statins, and other medications commonly used to treat nononcologic, non-autoimmune conditions are allowed.
  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. 
  • Prior or concurrent use of trastuzumab.
  • Prior or concurrent use of a PD-1 or PD-L1 checkpoint inhibitor including pembrolizumab unless the use was ≥ 3 months prior to randomization.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kathryn Ruddy, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Donald Northfelt, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Alvaro Moreno Aspitia, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20366156

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