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

NCT04540692 | Active Not Recruiting Phase 3

• 2 other identifiers: GBECAM 0419LACOG 0419
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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..

  An average of 8 years

Study Arms (2)

Start with Cyclophosphamide + Doxorrubicin

ACTIVE COMPARATOR

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.

Drug: Cyclophosphamide + Doxorrubicin

Start with Docetaxel or Paclitaxel

EXPERIMENTAL

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.

Drug: Docetaxel or Paclitaxel

Interventions

Docetaxel or Paclitaxel DRUG

Treatment will start with Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks

Also known as: Taxotere or Taxol

Start with Docetaxel or Paclitaxel

Cyclophosphamide + Doxorrubicin DRUG

Treatment will start with Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles

Also known as: Citoxan + Rubidox

Start with Cyclophosphamide + Doxorrubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

Sponsors & Collaborators

• Latin American Cooperative Oncology Group: lead
• Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM): collaborator

Study Sites (16)

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

Cachoeiro de Itapemirim, Espírito Santo, 29.308-065, Brazil

Location

Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel

Salvador, Estado de Bahia, 400.50-410, Brazil

Location

Centro de Pesquisa do Hospital Araújo Jorge

Goiânia, Goiás, 74.605-010, Brazil

Location

ICTR - Instituto do Câncer e Transplante de Curitiba

Curitiba, Paraná, 80.510-130, Brazil

Location

HUEM/CEON - Hospital Universitário Evangélico Mackenzie

Curitiba, Paraná, 80.730-150, Brazil

Location

Hospital Erasto Gaertner

Curitiba, Paraná, 81.520-060, Brazil

Location

IMIP - Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, 50.070-902, Brazil

Location

INCA - Instituto Nacional de Câncer

Rio de Janeiro, Rio de Janeiro, 20.230-130, Brazil

Location

HFOA - Hospital da Fundação Oswaldo Aranha

Volta Redonda, Rio de Janeiro, 27.251-260, Brazil

Location

HCPA - Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90.035-903, Brazil

Location

CEPON - Centro de Pesquisas Oncológicas

Florianópolis, Santa Catarina, 88.034-000, Brazil

Location

Hospital de Amor de Barretos

Barretos, São Paulo, 14.784-400, Brazil

Location

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

Botucatu, São Paulo, 18.618-686, Brazil

Location

Faculdade de Ciências Médicas da Unicamp

Campinas, São Paulo, 13.083-881, Brazil

Location

Hospital de Amor Jales - Hospital de Câncer de Barretos

Jales, São Paulo, 15.706-396, Brazil

Location

IBCC Oncologia - Núcleo de Pesquisa São Camilo

São Paulo, São Paulo, 04.014-002, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Paclitaxel; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• José Bines

  Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: September 7, 2020
• Study Start: January 12, 2021
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2030
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

BR (16)