Barretos Cancer Hospital
Barretos, São Paulo, 14784-400, Brazil
NCT Number: NCT02978495
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.
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Notify Me18 year and older
Female
Interventional
Phase 2
Barretos, São Paulo, 14784-400, Brazil
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Absolute neutrophil count > 1,500/mm3 Hemoglobin > 10.0 g/dl Platelet count > 100,000/mm3
Exclusion criteria
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
Time frame: within the first 21 days after surgery
Time frame: within the first 60 month after surgery
Time frame: within the first 60 month after surgery
Barretos Cancer Hospital
Other
Neoadjuvant Carboplatin in Triple Negative Breast Cancer - A Prospective Phase II Study (NACATRINE Trial).
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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