Phase III randomized clinical trial evaluating the sequencing of anthracyclines and taxanes in neoadjuvant therapy for locally advanced HER2-negative breast cancer.
Female participants, with at least 18 years old on the day of signing the free and informed consent;
Invasive breast carcinoma stage III (RH positive) or IIB/III (RH negative), according to TNM 8th edition; Histologically confirmed diagnosis of invasive breast carcinoma (with any histology), HER-2 negative;
The participant (or legally acceptable representative, if applicable) provides written informed consent for the study;
The participant must agree to use a contraceptive as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of the study treatment;
None
Parallel
Docetaxel or Paclitaxel
DrugTreatment will start with Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks
Cyclophosphamide + Doxorrubicin
DrugTreatment will start with Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles
Invasive disease-free survival (IDFS)
Defined as the time elapsed between the date of randomization and the date of invasive recurrence (excludes carcinoma in situ) or death, whichever comes first..
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Latin American Cooperative Oncology Group
Lead sponsor
Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
Collaborator
