RecruitingPhase 3NCT04540692

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

NEOSAMBA Clinical Trial - Stage I

Sponsor

Latin American Cooperative Oncology Group

Enrollment

444 participants

Start Date

Jan 12, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two sequences of giving chemotherapy drugs — whether anthracyclines (like doxorubicin) should come before or after taxanes (like paclitaxel) — as pre-surgery (neoadjuvant) treatment for locally advanced, HER2-negative breast cancer. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with stage IIB or III invasive breast cancer - Your cancer is HER2-negative (confirmed by biopsy) - You are willing to use contraception during and for at least 120 days after treatment - Your overall health is reasonable (ECOG score 0–2) **You may NOT be eligible if...** - You have HER2-positive breast cancer - You have already started treatment for this cancer - You have serious heart problems or other conditions that make chemotherapy unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDocetaxel 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

DRUGCyclophosphamide + Doxorrubicin

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

Locations(18)

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

Cachoeiro de Itapemirim, Espírito Santo, Brazil

Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel

Salvador, Estado de Bahia, Brazil

Centro de Pesquisa do Hospital Araújo Jorge

Goiânia, Goiás, Brazil

ICTR - Instituto do Câncer e Transplante de Curitiba

Curitiba, Paraná, Brazil

HUEM/CEON - Hospital Universitário Evangélico Mackenzie

Curitiba, Paraná, Brazil

Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

IMIP - Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, Brazil

Hospital Universitário Oswaldo Cruz (UNIPECLIN)

Recife, Pernambuco, Brazil

HINJA - Hospital Jardim Amália

Volta Redonda, Rio de Janeiro, Brazil

HCPA - Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

CEPON - Centro de Pesquisas Oncológicas

Florianópolis, Santa Catarina, Brazil

Hospital de Amor de Barretos

Barretos, São Paulo, Brazil

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

Botucatu, São Paulo, Brazil

Faculdade de Ciências Médicas da Unicamp

Campinas, São Paulo, Brazil

Hospital de Amor Jales - Hospital de Câncer de Barretos

Jales, São Paulo, Brazil

INCA - Instituto Nacional de Câncer

Rio de Janeiro, Brazil

ICESP - Instituto do Câncer do Estado de São Paulo

São Paulo, Brazil

IBCC Oncologia - Núcleo de Pesquisa São Camilo

São Paulo, Brazil

View Full Details on ClinicalTrials.gov

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NCT04540692

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