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Clinical Trials in Brazil / NCT04540692
Active, not recruiting Phase 3

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

NCT04540692 · tracked via the Priya Life Science Brazil tracker
Sponsor
Latin American Cooperative Oncology Group
Phase
Phase 3
Started
2021-01-12
Last updated
2026-09-02

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Docetaxel or PaclitaxelAll Docetaxel trials (271) →All Paclitaxel trials (416) →Cyclophosphamide + DoxorrubicinAll Cyclophosphamide trials (395) →All Doxorrubicin trials (2) →

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

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

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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO) Cachoeiro de Itapemirim Espírito Santo
Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel Salvador Estado de Bahia
Centro de Pesquisa do Hospital Araújo Jorge Goiânia Goiás
ICTR - Instituto do Câncer e Transplante de Curitiba Curitiba Paraná
HUEM/CEON - Hospital Universitário Evangélico Mackenzie Curitiba Paraná
Hospital Erasto Gaertner Curitiba Paraná
IMIP - Instituto de Medicina Integral Professor Fernando Figueira Recife Pernambuco
INCA - Instituto Nacional de Câncer Rio de Janeiro Rio de Janeiro
HFOA - Hospital da Fundação Oswaldo Aranha Volta Redonda Rio de Janeiro
HCPA - Hospital de Clinicas de Porto Alegre Porto Alegre Rio Grande do Sul
CEPON - Centro de Pesquisas Oncológicas Florianópolis Santa Catarina
Hospital de Amor de Barretos Barretos São Paulo
UNESP - Faculdade de Medicina da Universidade Estadual Paulista (UPECLIN) Botucatu São Paulo
Faculdade de Ciências Médicas da Unicamp Campinas São Paulo
Hospital de Amor Jales - Hospital de Câncer de Barretos Jales São Paulo
IBCC Oncologia - Núcleo de Pesquisa São Camilo São Paulo São Paulo

More Latin American Cooperative Oncology Group trials in Brazil

Amivantamab in Patients With Metastatic/Recurrent Penile Squamous Cell Carcinoma Starting soon
A Collaborative Trial of Niraparib to Evaluate Patients With Ovarian Cancer in the Expanded Access Program in Latin America Active, not recruiting
Oncogeriatric Screening and Evaluation Program Starting soon
Epidemiological Profile of Patients With IDH-Mutant Diffuse Gliomas Diagnosed From 2021 in Brazil Starting soon
Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil Starting soon

Other trials for the same condition

Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction Recruiting
A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer Active, not recruiting
CRYoablation for Small Tumors As Local Treatment - SIX Trial Recruiting
A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer Active, not recruiting
Pain Control in Breast Surgery: Analgesia, Opioid Consumption and Inflammatory Response Evaluation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04540692 on ClinicalTrials.gov ↗ ← All trials in Brazil