Procedures
neutropenia, toxicity, toxicities, clinically node-negative disease, anemia, Cancer
ADVERSE EVENT, METASTASIS, NEUTROPENIA, FEBRILE NEUTROPENIA, ADVERSE EVENT, THROMBOCYTOPENIA, DISEASE, ANEMIA, SENTINEL NODE, BLOOD, CANCER
All women were screened at baseline for distant metastasis with chest and abdomen tomography and bone scintigraphy. Blood samples were collected from all women at baseline to define BRCA1 and BRCA2 mutational status and storage at the BioBank of Barretos Cancer Hospital [According to the investigator's choice, a sentinel node procedure was done in patients with clinically node-negative disease before or after NACT.As summarized in Fig. S1 (supplementary material), the chemotherapy protocol consisted of doxorubicin (60 mg/mAn assessment of toxicity and laboratory tests preceded each chemotherapy cycle. Adverse events (AEs) were assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Dose adjustment criteria followed the protocol. In brief, in the case of grade 2 neutropenia, chemotherapy was allowed with granulocyte-colony-stimulating factor (G-CSF) prophylaxis at the investigator’s discretion. In the case of grade 3 or 4 neutropenia, or febrile neutropenia, chemotherapy was delayed and postponed until grade 1 with dose reduction according to local protocol. For anemia, thrombocytopenia, and non-hematological toxicities grade 3 or worse, chemotherapy was postponed and reinitiated with dose reduction when toxicity recovered to grade 1. Toxicity-based dose adjustments were carried out according to drug-specific standard guidelines. In the experimental arm, if necessary, carboplatin was discontinued after two dose reductions, and paclitaxel was continued as monotherapy.Patients underwent surgery within 3–6 weeks after the last chemotherapy cycle. The decision about performing breast-conserving surgery (BCS) or mastectomy depended on the patient’s and surgeon’s preferences and followed institutional guidelines. In patients with clinically node-positive disease after chemotherapy, axillary dissection was required. In patients with clinically node-negative disease, the timing (before or after neoadjuvant therapy) of sentinel node biopsy was at the investigator's local practice. Adjuvant radiotherapy was given according to local practice. All randomized patients remained in the study and follow-up.