Cancer Vaccine + GM-CSF and Cyclophosphamide for Triple Negative Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of a special vaccine, an immune booster, and a chemotherapy drug to prevent the return of triple negative breast cancer. It aims to help the immune system fight off cancer cells and use chemotherapy to kill any remaining ones.
Who Is on the Research Team?
Kathryn J Ruddy
Principal Investigator
Academic and Community Cancer Research United
Are You a Good Fit for This Trial?
This trial is for women aged 18+ with stage 1-3 triple negative breast cancer who've completed surgery and other treatments within the past 90 to 546 days. They must have a good performance status, adequate organ function, and no evidence of metastatic disease or recurrence. Women must not be pregnant, nursing, immunocompromised on antiretroviral therapy, or have active autoimmune diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cyclophosphamide and either the multi-epitope folate receptor alpha peptide vaccine with sargramostim or a placebo vaccine with sargramostim. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14.
Follow-up
Participants are monitored for disease-free survival and adverse events every 6 months for 3 years after completion of study treatment.
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Multi-epitope Folate Receptor Alpha Peptide Vaccine
- Sargramostim
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Academic and Community Cancer Research United
Lead Sponsor
National Cancer Institute (NCI)
Collaborator