Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer
444 patients around the world
Available in Brazil
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.
Latin American Cooperative Oncology Group
18Research sites
444Patients around the world
Requirements for the patient
From 18 Years
Female
Medical requirements
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.
Sites
Hospital Araújo Jorge
Recruiting
R. 239, 206 - Setor Leste Universitário, Goiânia - GO, 74605-070
Hospital Jardim Amália
Recruiting
Av. Governador Leonel de Moura Brizola, 490 - Cidade dos Meninos, Duque de Caxias - RJ, 25237-010
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Recruiting
Natal, Rio Grande Do Norte, 59075-740
Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
Recruiting
Rua Ramiro Barcelos, 2350, Av. Protásio Alves, 211 - Santa Cecília, Porto Alegre - RS, 90035-903
INSCER - Instituto do Cérebro da PUC-RS
Recruiting
Av. Ipiranga, 6690, 4o Andar, Centro de Pesquisa Clínica do HSLPUCRS - Jardim Botânico – Porto Alegre/RS - 90610-000
Centro Pesquisas Oncologicas - CEPON
Recruiting
655 Rio Itacorubi Florianópolis SC BR 88034-000, Rod. Admar Gonzaga - Itacorubi, Florianópolis - SC
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
Rua Antenor Duarte Villela 1331 - Barretos, Sao Paulo, 14784-400
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Recruiting
Av. Dr. Arnaldo, 251 - Consolação, São Paulo - SP, 01255-090, Brazil
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Recruiting
Pr. da Cruz Vermelha, 23 - Centro, Rio de Janeiro - RJ, 20230-130
Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de Controle do Cancer - IBC