Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Pat… (NCT03012100) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer
United States280 participantsStarted 2017-03-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>= 18 years
* Female
* 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 CANCER surgeries, any radiation therapy, and any chemotherapy, whichever is last, \>= 90 days but not \>= 546 days prior to randomization
* Note: Reconstructive and prophylactic surgeries are allowed after randomization (during study treatment)
* 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 di…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 2 and is testing a folate receptor alpha peptide vaccine combined with GM-CSF and cyclophosphamide for triple negative breast cancer — what does Phase 2 mean for how much is actually known about whether this vaccine approach works and how safe it is?
2Since the trial is actively enrolling but no longer recruiting new patients, is there any way for me to still access this vaccine regimen, or are there similar trials I should be looking into instead?
3The trial is measuring disease-free survival as its main goal — how does that outcome measure compare to what standard treatments for my stage of triple negative breast cancer are already achieving?
4This approach uses cyclophosphamide alongside the vaccine, which is a chemotherapy drug — what side effects or risks should I be aware of from combining an immune-stimulating vaccine with cyclophosphamide, especially compared to my current treatment plan?
5Given that my specific stage and type of breast cancer may or may not match what this trial was designed for, can you look at the eligibility criteria and tell me whether my situation aligns with the kind of patients this trial was built around?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disease-free Survival
Timeframe: 7 years
Trial details
NCT IDNCT03012100
SponsorAcademic and Community Cancer Research United