Clinical Trial: Neoadjuvant Carboplatin in Triple Negative Breast Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Barretos Cancer Hospital

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Barretos Cancer Hospital

Dates:
Date Received: November 24, 2016
Date Started: May 17, 2017
Date Completion: December 2022
Last Updated: May 17, 2017
Last Verified: May 2017