Breast cancer is the most frequent neoplasm in women in Brazil and in the world and up to 15% of all cases diagnosed correspond to the triple negative subtype. Triple negative breast cancer affects young women with germline mutations in BRCA 1/2 genes. Giving the lack of target therapies to date, there is no consensus regarding the most effective treatment for this subgroup of tumors. Although evidence shows that triple negative breast cancer is highly sensitive to chemotherapy when compared to other breast tumors, there is no evidence to support the hypothesis that patients with triple negative breast cancer and mutation in BRCA1 / 2 genes have higher chemosensitivity to neoadjuvant therapy. The investigator proposes a prospective, randomized, open-label, phase II study, evaluating the rate of complete pathologic response, disease-free survival, overall survival and prognostic evaluation of BRCA1 / 2 mutation status in women with triple negative breast cancer submitted to sequential neoadjuvant chemotherapy based on anthracycline and taxane, with or without carboplatin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Doxorrubicin 60 mg/m2 4 cycles each 21 days
Carboplatin AUC 1,5 once a week, for 12 weeks
80mg/m2 weekly for 12 weeks
600mg/m2 4 cycles each 21 days
Barretos Cancer Hospital
Barretos, São Paulo, Brazil
Pathological complete response (pCR), defined as absence of invasive cancer in the breast and axillary lymph nodes.
Time frame: within the first 21 days after surgery
Disease free survival (DFS)
Time frame: within the first 60 month after surgery
Overall survival (OS)
Time frame: within the first 60 month after surgery
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