Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer (NEOSAMBA)
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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;
- Have a functional capacity according to the Eastern Cooperative Oncology Group (ECOG) from 0 to 2. The evaluation of the ECOG must be carried out within 7 days before the inclusion date.
- Have adequate organic function. The samples must be collected within 60 days before the start of the study treatment;
- Have adequate cardiac function as assessed by echocardiogram or MUGA performed up to 60 days before the start of treatment under study.
Exclusion Criteria:
- Individuals who do not meet the inclusion criteria above-mentioned.
Sites / Locations
- Centro de Pesquisa do Setor de Ginecologia e Mama do Hospital Araújo JorgeRecruiting
- ICTr
- Hospital Jardim AmáliaRecruiting
- Centro de Pesquisa Clínica da Liga Norte Riograndense Contra o CâncerRecruiting
- Hospital de Clínicas de Porto AlegreRecruiting
- Centro de Pesquisa em Oncologia PUCRS
- Centro de Pesquisas Oncológicas - CEPONRecruiting
- Hospital de Câncer de BarretosRecruiting
- IBCCRecruiting
- ICESP
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Start with Cyclophosphamide + Doxorrubicin
Start with Docetaxel or Paclitaxel
Patients will receive the following treatment schedule: Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles, followed by docetaxel 75-100mg/m2 intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m2 for 12 weeks.
Patients will receive the following treatment schedule: Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks, followed by Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days, for 3 cycles.