Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT04540692
- Lead Sponsor
- Latin American Cooperative Oncology Group
- Brief Summary
Phase III randomized clinical trial evaluating the sequencing of anthracyclines and taxanes in neoadjuvant therapy for locally advanced HER2-negative breast cancer.
- Detailed Description
Multicenter, phase III, open-label, randomized clinical trial, which will include 494 patients randomized to two neoadjuvant chemotherapy arms. The treatment protocol will be the same in both groups, only the regimens sequences will be evaluated: starting with anthracycline versus taxane, with or without carboplatin for patients with triple negative subtype. The chemotherapy regimen will follow the institution's routine, which includes the use of CA in the anthracyclical phase and, in the taxane phase, the use of docetaxel every 21 days or weekly paclitaxel. The rest of the treatment (surgery, radiotherapy, hormone therapy) will not be part of the study and will be carried out according to institutional guidelines.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 444
- 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.
- Individuals who do not meet the inclusion criteria above-mentioned.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Start with Docetaxel or Paclitaxel Docetaxel or Paclitaxel 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. Start with Cyclophosphamide + Doxorrubicin Cyclophosphamide + Doxorrubicin 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.
- Primary Outcome Measures
Name Time Method Invasive disease-free survival (IDFS) An average of 8 years 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..
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
HINJA - Hospital Jardim Amália
🇧🇷Volta Redonda, Rio De Janeiro, Brazil
HCPA - Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Amor de Barretos
🇧🇷Barretos, São Paulo, Brazil
CEPON - Centro de Pesquisas Oncológicas
🇧🇷Florianópolis, Santa Catarina, Brazil
Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel
🇧🇷Salvador, Bahia, Brazil
Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)
🇧🇷Cachoeiro De Itapemirim, Espírito Santo, Brazil
INCA - Instituto Nacional de Câncer
🇧🇷Rio De Janeiro, Brazil
IBCC Oncologia - Núcleo de Pesquisa São Camilo
🇧🇷São Paulo, Brazil
ICESP - Instituto do Câncer do Estado de São Paulo
🇧🇷São Paulo, Brazil
HUEM/CEON - Hospital Universitário Evangélico Mackenzie
🇧🇷Curitiba, Paraná, Brazil
Hospital de Amor Jales - Hospital de Câncer de Barretos
🇧🇷Jales, São Paulo, Brazil
IMIP - Instituto de Medicina Integral Professor Fernando Figueira
🇧🇷Recife, Pernambuco, Brazil
ICTR - Instituto do Câncer e Transplante de Curitiba
🇧🇷Curitiba, Paraná, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista (UPECLIN)
🇧🇷Botucatu, São Paulo, Brazil
Hospital Erasto Gaertner
🇧🇷Curitiba, Paraná, Brazil
Faculdade de Ciências Médicas da Unicamp
🇧🇷Campinas, São Paulo, Brazil
Hospital Universitário Oswaldo Cruz (UNIPECLIN)
🇧🇷Recife, Pernambuco, Brazil
Centro de Pesquisa do Hospital Araújo Jorge
🇧🇷Goiânia, Goiás, Brazil