Study design and participants
tumor, cancer, TNBC, Triple-negative, Cancer
TUMOR, METASTASIS, CANCER, RESOLUTION, CANCER
The NACATRINE trial is a phase II, single-center, randomized, open-label study that investigated the addition of carboplatin to paclitaxel after standard anthracycline/cyclophosphamide NAC in 146 patients with TNBC (NCT02978495). Eligible patients were women (aged ≥ 18 years) with previously untreated, stage II–III, histologically confirmed TNBC and considered candidates for NAC. The main exclusion criteria were evidence of distant metastasis, pregnancy or lactation status, administration of any other antineoplastic treatment concomitant with the study treatment, and unavailability of tumor samples. The NACATRINE study design is (Supplementary Fig.  All patients underwent systemic staging comprising chest and abdominal computed tomography and bone scans. Triple-negative status was determined based on central immunohistochemistry analyses and defined as estrogen receptor (ER) negative (expression in < 1% of the cancer cells), progesterone receptor negative (expression in < 1% of the cancer cells), and human epidermal growth factor receptor-type 2 (HER2) negative (0 or 1 + or 2 + with a negative fluorescence in situ hybridization test).Written informed consent was obtained from all patients. The study protocol and all subsequent amendments were approved by the institutional ethics committee (institutional review board) of Barretos Cancer Hospital (1.796.766) and was registered at ClinicalTrials.gov under the number NCT02978495. All patients signed voluntary informed consent before study entry. We declare that this study was faithful to the Declaration of Helsinki (1964 and its subsequent versions of 1975, 1983, 1989, 1996, 2000 and 2008) and Resolution 466 of 2012 of the National Health Council (CNS). In this way, the autonomy of the participants was guaranteed and the commitment to maximum benefit and minimum risk.