NCT02978495

Neoadjuvant Carboplatin in Triple Negative Breast Cancer

Neoadjuvant Carboplatin in Triple Negative Breast Cancer - A Prospective Phase II Study (NACATRINE Trial).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Barretos Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• BRCA1 Hereditary Breast and Ovarian Cancer Syndrome

Interventions

Type	Name	Description
DRUG	Doxorubicin	Doxorrubicin 60 mg/m2 4 cycles each 21 days
DRUG	Carboplatin	Carboplatin AUC 1,5 once a week, for 12 weeks
DRUG	Paclitaxel	80mg/m2 weekly for 12 weeks
DRUG	Cyclophosphamide	600mg/m2 4 cycles each 21 days

Timeline

• Start date: 2017-05-17
• Primary completion: 2019-12-02
• Completion: 2021-10-22
• First posted: 2016-12-01
• Last updated: 2022-12-28

Locations

1 site across 1 country: Brazil