This trial is evaluating whether AE37 Peptide vaccine will improve 2 primary outcomes and 4 secondary outcomes in patients with Triple Negative Breast Neoplasms. Measurement will happen over the course of Adverse events assessed from the beginning of study therapy through 90 days after the last dose of study therapy.
This trial requires 29 total participants across 2 different treatment groups
This trial involves 2 different treatments. AE37 Peptide Vaccine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
Triple negative breast carcinomas are a rare but challenging group of tumors, which are often aggressive and hard to manage, and may be associated with poor survival. A better understanding of the genetics and molecular bases of this subset of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s is required to make improvements in prevention, diagnosis, and treatment. Cancer 2013;121:721-6. © 2013 American Cancer Society.
TNBC incidence has increased significantly over the last 50 years; however, many of the contributing factors have not yet been determined. The age-standardized rates of TNBC remain relatively low in the US overall. These trends were more pronounced in African-American women. TNBC incidence rates appear to have significantly increased among young, black women, women from low-income and rural backgrounds, and those with BRCA mutations.
It is proposed that the development of triple negative-type breast tumors is caused by the accumulation of several environmental, behavioral, genetic, and hormonal factors. The findings presented in this article show that there exists an association between tobacco consumption and triple negative-type breast cancer with a greater number of triple negative breast tumors occurring in the elderly.
TNBC is a diverse heterogenous group, with a range of clinical patterns. The most common type of TNBC is ER-, PR-, and HER2-, which may be the basis for the development of targeted therapies, that is, monoclonal antibodies and aromatase inhibitors. In rarer variants of TNBC, such as ALK-positive, ER-positive and/or PR-positive, it is important to be familiar with therapeutic options such as targeted therapies, taxanes, anthracyclines, and/or platinum-based chemotherapy. We propose a more explicit nomenclature for TNBC, as well as, a more complete clinical description of TNBC subtypes.
For TNBC, the majority of treatment trials and meta-analyses were published before 2010. Most reviewed agents were in their first or second-line and only a minority of agents had clinical evidence suggesting improved disease progression, recurrence, or survival. Clinical trials are ongoing, especially trials addressing adjuvant therapies which could help prevent recurrence and treatment of metastatic breast cancer.
In some TNBC patients, surgery followed by adjuvant chemotherapy and radiotherapy are sufficient to allow long-term disease-free survival, but the risks of long-term adverse treatment effects for these women might preclude complete surgical removal of TNBC. This fact should be taken into account when choosing management of TNBC patients.
About 30% of women with [triple negative breast cancer](https://www.withpower.com/clinical-trials/triple-negative-breast-cancer) will develop distant metastases at some point while the disease is in a stage of localized growth. Approximately 4% of women will also develop distant metastases while the cancer remains localized. When triple negative breast cancer is metastatic, the survival rate is about 50%. Survival is dependent upon the type of metastase (bone or visceral) and the site of the metastasis. If the metastases are limited to the bones, the prognosis is favorable. If bone metastases only are present, about 55% of patients who develop metastases will have a favorable outcome. Women who develop distant metastases also have less favorable survival.
Patients with triple negative breast neoplasms have a higher frequency of a family history. Although the underlying molecular and pathological cause of hereditary [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) still needs to be discovered, the findings of this study add clinical evidence that a family history of triple negative cancers should be investigated.
The clinical features associated with [triple negative breast cancer](https://www.withpower.com/clinical-trials/triple-negative-breast-cancer) might be different to those of other cancers such as ductal carcinoma and lobular carcinoma. The management of patients with triple negative breast cancer should therefore be tailored to their specific features. Local recurrence-free survival is important in evaluating the efficacy of any treatment for triple negative breast cancer.
The treatment approaches, like the neoadjuvant chemotherapy, have not been proven helpful in the management of TNBC. The latest knowledge suggests that adjuvant-only chemotherapy, including palliative chemotherapy and trastuzumab, has been proven feasible for TNBC. However, the benefit of neoadjuvant chemotherapy in TNBC remains to be proven.
Vaccination with ae37 peptide elicited potent humoral and cellular immune responses when used in combination with rEP-3 (a synthetic analog of the mammary-epithelial growth factor (mEGF)) as adjuvants in HER2-positive and triple-negative breast cancer patients. Furthermore, ae37 peptide vaccination with or without adjuvants was shown to prolong survival.