Molecular Profiling After Neoadjuvant Chemotherapy for Triple-negative Breast Cancer
Molecular Profiling After Neoadjuvant Chemotherapy for Triple-negative Breast Cancer
Neoadjuvant chemotherapy (NACT) can induce complete pathologic response (pCR) in
 approximately 35-55% of patient with triple-negative breast cancer (TNBC). These patients
 have excellent long term survivals. On the other hand patients with residual disease exhibit
 a high rate of local or metastatic. Although it has been successful in some regards,
 randomized trials have shown similar rates of mortality between patients receiving NACT and
 adjuvant chemotherapy (ACT). The goal of this study is to understand the molecular biology
 (gene expression signature) driving treatment-resistant TNBC. The investigators are planning
 to identify targetable genetic alterations which may help to optimize adjuvant therapy for
 the patient with residual TNBC.
In this study, investigators will understand the clinical relevance of genomic heterogeneity
 of triple-negative breast cancer by determining pathological complete response (pCR) rates
 after NACT, based on genomic profiling of individual tumors. Investigators will identify new
 genomic alterations in patients with residual TNBC as well as in patients who develop
 metastatic disease within 24 months after completion of all appropriate therapies.
 Investigators will demonstrate unique genomic alteration, and we will identify new tumor
 markers in Hispanic/Latino (H/L) women with TNBC.

 Inclusion Criteria:

 This study aims to include all patients with early stage (I-III) TNBC who received NACT and
 subsequently underwent surgical treatment (mastectomy or lumpectomy) or women with
 triple-negative breast cancer who progressed and developed metastatic disease within 24
 months after all appropriate therapies.

 1. Age > 18 or <86 years of age, for Hispanic/Latino women we will use the National
 Advisory Committee on Racial, Ethnic and Other populations NAC definition which is (the
 ethnonyms "Hispanic" and "Latino" to refer collectively to the inhabitants of the United
 States of America who are of Latin American or Spanish origin-that is, Latino or
 Hispanic Americans).

 2. Pre- and Post - menopausal women with histologically confirmed hormonal receptor
 negative (ER and/or PR <1%), Her2-neu - negative (by IHC or/and FISH) invasive breast
 cancer stages I - III or with metastatic triple-negative breast cancer (if develop
 metastatic disease during the chemotherapy or within 24 months after completion of all
 appropriate treatments).

 3. Patients must be eligible for NACT, and surgical lumpectomy or mastectomy.

 4. All patients or their legally authorized representative must be informed of the
 investigational nature of this study and must sign and give written informed consent in
 accordance with Institutional and Federal guidelines.

 Exclusion Criteria:

 1. Women < 18 or >86 years of age

 2. ER/PR- positive, Her-2 neu - positive breast cancer.
Inclusion Criteria:

 1. Age > 18 or <86 years of age, for Hispanic/Latino women we will use the National
 Advisory Committee on Racial, Ethnic and Other populations NAC definition which is
 (the ethnonyms "Hispanic" and "Latino" to refer collectively to the inhabitants of the
 United States of America who are of Latin American or Spanish origin-that is, Latino
 or Hispanic Americans).

 2. Pre- and Post - menopausal women with histologically confirmed hormonal receptor
 negative (ER and/or PR <1%), Her2-neu - negative (by IHC or/and FISH) invasive breast
 cancer stages I - III or with metastatic triple-negative breast cancer (if develop
 metastatic disease during the chemotherapy or within 24 months after completion of all
 appropriate treatments).

 3. Patient must be eligible for neo-adjuvant chemotherapy, and surgical lumpectomy or
 mastectomy.

 4. All patients or their legally authorized representative must be informed of the
 investigational nature of this study and must sign and give written informed consent
 in accordance with Institutional and Federal guidelines.

 Exclusion Criteria:

 1. Women < 18 or >86 years of age

 2. ER/PR- positive, Her-2 neu - positive breast cancer.