Multi-epitope Folate Receptor Alpha Peptide Vaccine for Stage IIB Breast Cancer AJCC v6 and v7

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic in Arizona, Scottsdale, AZ
Stage IIB Breast Cancer AJCC v6 and v7+15 More
Multi-epitope Folate Receptor Alpha Peptide Vaccine - Biological
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of a vaccine and chemotherapy may help prevent the recurrence of triple negative breast cancer.

See full description

Eligible Conditions

  • Stage IIB Breast Cancer AJCC v6 and v7
  • Bilateral Breast Carcinoma
  • Stage IB Breast Cancer AJCC v7
  • Stage IIA Breast Cancer AJCC v6 and v7
  • Inflammatory Breast Carcinoma
  • Stage II Breast Cancer AJCC v6 and v7
  • Stage III Breast Cancer AJCC v7
  • Stage IIIA Breast Cancer AJCC v7
  • Stage IIIB Breast Cancer AJCC v7
  • Stage IIIC Breast Cancer AJCC v7
  • Unilateral Breast Carcinoma
  • Triple Negative Breast Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Multi-epitope Folate Receptor Alpha Peptide Vaccine will improve 1 primary outcome and 4 secondary outcomes in patients with Stage IIB Breast Cancer AJCC v6 and v7. Measurement will happen over the course of Through study completion (average of 5 years).

Year 5
Disease-free survival
FRalpha levels
Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events 4.0
Overall survival
Vaccine induced folate receptor [FR]alpha-specific T cell responses defined as the proportion of patients with at least a 2-fold increase in the number of cells/plasma concentration

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm I (FRalpha peptide vaccine, sargramostim)
1 of 2
Arm II (placebo, sargramostim)
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 280 total participants across 2 different treatment groups

This trial involves 2 different treatments. Multi-epitope Folate Receptor Alpha Peptide Vaccine is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm I (FRalpha peptide vaccine, sargramostim)Patients receive cyclophosphamide PO BID on days 1-7 and 15-21 of cycle 1 only. Starting cycle 2, patients receive multi-epitope folate receptor alpha peptide vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.
Arm II (placebo, sargramostim)Patients receive cyclophosphamide as in Arm I. Starting cycle 2, patients receive placebo vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
FDA approved
Cyclophosphamide
FDA approved
Folic acid
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion (average of 5 years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion (average of 5 years) for reporting.

Closest Location

Mayo Clinic in Arizona - Scottsdale, AZ

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Stage IIB Breast Cancer AJCC v6 and v7 or one of the other 15 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
HER2 IHC expression of 2+ 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
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
IHC not done and in-situ hybridization non-amplified
Note: Reconstructive and prophylactic surgeries are allowed after randomization (during study treatment)
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

Patient Q&A Section

What causes triple negative breast neoplasms?

"The triple-negative breast neoplasms have a different genetic profile from the other subtypes. This may provide a means for defining subgroups within the triple-negative subtype that might respond differently to therapies." - Anonymous Online Contributor

Unverified Answer

Can triple negative breast neoplasms be cured?

"TNBC have a dismal treatment outcome. Even when treated, a significant proportion of patients will require systemic therapy, while others are still alive. The vast majority of patients with high grade TNBC will not live beyond 4 years." - Anonymous Online Contributor

Unverified Answer

What are the signs of triple negative breast neoplasms?

"The authors found that TNBCs commonly display the following: a palpable lump, axillary lymphadenopathy, diffuse axillary or periclavicular axillary fat, and an elevated serum HER2 level or positive immunostaining of the tumor. TNBCs that displayed a palpable mass with axillary or bilateral axillary lymphadenopathy were found to present with a higher disease burden, lower lymph node positivity, lower rate of tumor-free survival, and shorter overall survival; therefore, these patients are at a greater risk for early local recurrence." - Anonymous Online Contributor

Unverified Answer

What are common treatments for triple negative breast neoplasms?

"There is still not a lot of information available about the treatment options for [triple negative breast cancer](https://www.withpower.com/clinical-trials/triple-negative-breast-cancer). There is some evidence from clinical trial that suggests that certain treatments which include taxol, trastuzumab and docetaxel have higher survival for triple negative cancer compared to standard chemotherapy. However, due to lack of big data, treatment options still remain to be established." - Anonymous Online Contributor

Unverified Answer

How many people get triple negative breast neoplasms a year in the United States?

"There are approximately 14,000 new cases of TNBC a year in US. These patients may represent 20% of tumors presenting in US women. TNBC is most common among young women (18-55). The proportion of [triple negative breast cancer](https://www.withpower.com/clinical-trials/triple-negative-breast-cancer) (TNBC) is approximately 14% among patients with breast cancer." - Anonymous Online Contributor

Unverified Answer

What is triple negative breast neoplasms?

"Unlike other breast cancers in the TNM staging system, triple-negative breast cancers are not subdivided into subsets by the numbers of positive lymph nodes. As a result, the TNM staging system assigns the same numbers to triple-negatives at any stage. Thus, the presence of a single negative axillary lymph node is not an appropriate indication to limit adjuvant therapy." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets triple negative breast neoplasms?

"The time-period analysis from our center suggests that a patient diagnosed with a TNBC, is a "younger" age who survives longer than patients diagnosed with other types of breast cancer. The "older" patients are diagnosed with triple negative tumors at early stages of disease and respond to treatment, most likely due to the lower incidence of ER and PR in these patients." - Anonymous Online Contributor

Unverified Answer

Does multi-epitope folate receptor alpha peptide vaccine improve quality of life for those with triple negative breast neoplasms?

"Inclusion of the multi-epitope, FOLR1 peptide vaccines in metastatic stage triple-negative luminal B mastoma treatment regimen is effective in both suppressing the disease and improving quality of life and might be a promising treatment strategy for this disease." - Anonymous Online Contributor

Unverified Answer

Has multi-epitope folate receptor alpha peptide vaccine proven to be more effective than a placebo?

"The multi-epitope FOLR alpha peptide vaccine can induce both antigen-specific and -independent immune responses in vivo, and can improve survival of triple negative breast cancer transplanted NOD/SCID recipients." - Anonymous Online Contributor

Unverified Answer

Does triple negative breast neoplasms run in families?

"We find no evidence of an association between TNB and other cancers in families and the TNB occurrence. In a previous paper (Golouzei et al., 1987 [A Case of Infant TNBC and Breast Cancer in a Father-Sons Pair, Proceedings of the American College of Radiology. Vol. 63, No. 5, May 1987, p.937-939]). We found a high prevalence of other mammary neoplasms in women with bilateral [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s. If we consider the association with breast cancer only, we cannot exclude the hypothesis of a genetic predisposition to breast neoplasms or the possible involvement of a gene at 17q21 in predisposing to TNB." - Anonymous Online Contributor

Unverified Answer

What is multi-epitope folate receptor alpha peptide vaccine?

"Findings from a recent study indicate a potential role for the folate receptor alpha peptide vaccine as part of a cancer immunotherapy strategy for patients with triple negative breast cancers, with its potential to enhance T cell responses to other antigen complexes present on cancer cells." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for triple negative breast neoplasms?

"Women ≥ 45 and presenting with tumors >1 cm larger than 0 and 1 cm larger than 0 and TNBC, should consider clinical trials if metastasis-free and overall survival are important to improving QOL. Women ≤ 45 presenting with tumors ≥ 5 mm or larger than 0 mm and TNBC, should not consider clinical trials, but, if progression-free and overall survival are critical, should consider clinical trials if metastasis-free and overall survival are important to improving QOL. Patient education will maximize enrollment and trial results." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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