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).
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.
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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