Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer

Last updated: June 3, 2024
Sponsor: Latin American Cooperative Oncology Group
Overall Status: Active - Recruiting

Phase

3

Condition

Breast Cancer

Cancer

Treatment

Cyclophosphamide + Doxorrubicin

Docetaxel or Paclitaxel

Clinical Study ID

NCT04540692
GBECAM 0419
LACOG 0419
  • Ages > 18
  • Female

Study Summary

Phase III randomized clinical trial evaluating the sequencing of anthracyclines and taxanes in neoadjuvant therapy for locally advanced HER2-negative breast cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female participants, with at least 18 years old on the day of signing the free andinformed consent;

  • Invasive breast carcinoma stage III (RH positive) or IIB/III (RH negative),according to TNM 8th edition; Histologically confirmed diagnosis of invasive breastcarcinoma (with any histology), HER-2 negative;

  • The participant (or legally acceptable representative, if applicable) provideswritten informed consent for the study;

  • The participant must agree to use a contraceptive as detailed in Appendix B of thisprotocol during the treatment period and for at least 120 days after the last doseof 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 daysbefore the inclusion date.

  • Have adequate organic function. The samples must be collected within 60 days beforethe 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

Exclusion Criteria:

  • Individuals who do not meet the inclusion criteria above-mentioned.

Study Design

Total Participants: 444
Treatment Group(s): 2
Primary Treatment: Cyclophosphamide + Doxorrubicin
Phase: 3
Study Start date:
January 12, 2021
Estimated Completion Date:
August 31, 2030

Study 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.

Connect with a study center

  • Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel

    Salvador, Bahia 400.50-410
    Brazil

    Active - Recruiting

  • Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)

    Cachoeiro De Itapemirim, Espírito Santo 29.308-065
    Brazil

    Active - Recruiting

  • Centro de Pesquisa do Hospital Araújo Jorge

    Goiânia, Goiás 74.605-010
    Brazil

    Active - Recruiting

  • Centro de Pesquisa do Setor de Ginecologia e Mama do Hospital Araújo Jorge

    Goiânia, Goiás
    Brazil

    Active - Recruiting

  • HUEM/CEON - Hospital Universitário Evangélico Mackenzie

    Curitiba, Paraná 80.730-150
    Brazil

    Active - Recruiting

  • Hospital Erasto Gaertner

    Curitiba, Paraná 81.520-060
    Brazil

    Active - Recruiting

  • ICTR - Instituto do Câncer e Transplante de Curitiba

    Curitiba, Paraná 80.510-130
    Brazil

    Active - Recruiting

  • ICTr

    Curitiba, Paraná
    Brazil

    Site Not Available

  • Hospital Universitário Oswaldo Cruz (UNIPECLIN)

    Recife, Pernambuco 50.110-130
    Brazil

    Active - Recruiting

  • IMIP - Instituto de Medicina Integral Professor Fernando Figueira

    Recife, Pernambuco 50.070-902
    Brazil

    Active - Recruiting

  • Centro de Pesquisa em Oncologia PUCRS

    Porto Alegre, RS
    Brazil

    Site Not Available

  • HINJA - Hospital Jardim Amália

    Volta Redonda, Rio De Janeiro 27.251-260
    Brazil

    Active - Recruiting

  • Hospital Jardim Amália

    Volta Redonda, Rio De Janeiro
    Brazil

    Active - Recruiting

  • Centro de Pesquisa Clínica da Liga Norte Riograndense Contra o Câncer

    Natal, Rio Grande Do Norte
    Brazil

    Site Not Available

  • HCPA - Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90.035-903
    Brazil

    Active - Recruiting

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul
    Brazil

    Active - Recruiting

  • CEPON - Centro de Pesquisas Oncológicas

    Florianópolis, Santa Catarina 88.034-000
    Brazil

    Active - Recruiting

  • Centro de Pesquisas Oncológicas - CEPON

    Florianópolis, Santa Catarina
    Brazil

    Active - Recruiting

  • Hospital de Amor de Barretos

    Barretos, São Paulo 14.784-400
    Brazil

    Active - Recruiting

  • Hospital de Câncer de Barretos

    Barretos, São Paulo
    Brazil

    Active - Recruiting

  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista (UPECLIN)

    Botucatu, São Paulo 18.618-686
    Brazil

    Active - Recruiting

  • Faculdade de Ciências Médicas da Unicamp

    Campinas, São Paulo 13.083-881
    Brazil

    Active - Recruiting

  • Hospital de Amor Jales - Hospital de Câncer de Barretos

    Jales, São Paulo 15.706-396
    Brazil

    Active - Recruiting

  • INCA - Instituto Nacional de Câncer

    Rio De Janeiro, 20.230-130
    Brazil

    Active - Recruiting

  • IBCC

    São Paulo,
    Brazil

    Active - Recruiting

  • IBCC Oncologia - Núcleo de Pesquisa São Camilo

    São Paulo, 04.014-002
    Brazil

    Active - Recruiting

  • ICESP

    São Paulo,
    Brazil

    Site Not Available

  • ICESP - Instituto do Câncer do Estado de São Paulo

    São Paulo, 01.246-000
    Brazil

    Active - Recruiting

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