A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America

NCT ID: NCT04158258

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2907 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-21

Study Completion Date

2026-06-30

Brief Summary

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A Prospective, Multicenter, Non-Interventional Study of Primary Data Collection, Designed to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcomes in Patients with Breast Cancer in Latin America.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bevacizumab

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Bevacizumab

Intervention Type DRUG

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Trastuzumab

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Trastuzumab

Intervention Type DRUG

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Ado-trastuzumab emtamsine

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Ado-trastuzumab emtamsine

Intervention Type DRUG

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Pertuzumab

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Pertuzumab

Intervention Type DRUG

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Atezolizumab

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Atezolizumab

Intervention Type DRUG

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Capecitabine

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Capecitabine

Intervention Type DRUG

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Interventions

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Bevacizumab

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Intervention Type DRUG

Trastuzumab

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Intervention Type DRUG

Ado-trastuzumab emtamsine

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Intervention Type DRUG

Pertuzumab

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Intervention Type DRUG

Atezolizumab

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Intervention Type DRUG

Capecitabine

Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.

Intervention Type DRUG

Other Intervention Names

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Avastin Herceptin Kadcyla Perjeta Tecentriq

Eligibility Criteria

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Inclusion Criteria

* Histological confirmed newly diagnosed stage I to IV (recurrent or de novo) breast cancer no more than 12 months prior to site activation, although they can have received anti-cancer treatment during that time

Exclusion Criteria

* Patients not receiving treatment for breast cancer with national approved drugs according to standard of care and in line with the current summary of product characteristics (SPC) /local labeling
* Patients not receiving the Roche studied medicinal product, but a biosimilar
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Latin American Cooperative Oncology Group

OTHER

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Instituto Alexander Fleming

Buenos Aires, , Argentina

Site Status

Instituto Oncologico De Cordoba

Córdoba, , Argentina

Site Status

Hospital Privado Centro Medico de Cordoba

Córdoba, , Argentina

Site Status

Hospital de Morón

Morón, , Argentina

Site Status

Instituto de Oncología de Rosario

Rosario, , Argentina

Site Status

Sanatorio de la Mujer

Rosario, , Argentina

Site Status

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Site Status

Hospital do Câncer de Londrina

Londrina, Paraná, Brazil

Site Status

Hospital Jardim Amália

Volta Redonda, Rio de Janeiro, Brazil

Site Status

Inst. de Vita

Caxias do Sul, Rio Grande do Sul, Brazil

Site Status

Centro de Pesquisa em Oncologia

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Instituto Nacional de Cancer - INCa

Rio de Janeiro, , Brazil

Site Status

Instituto Brasileiro De Controle Do Câncer - IBCC

São Paulo, , Brazil

Site Status

Clinica Las Condes

Santiago, , Chile

Site Status

Instituto Nacional del Cancer

Santiago, , Chile

Site Status

Hospital Dr. Hernan Henriquez Aravena

Temuco, , Chile

Site Status

Organización Clínica Bonnadona Prevenir S.A.S

Barranquilla, , Colombia

Site Status

Inst. Nacional de Cancerologia

Bogotá, , Colombia

Site Status

Centro Medico Imbanaco

Cali, , Colombia

Site Status

Fundacion Cardiovascular de Colombia - Instituto del Corazón

Floridablanca, , Colombia

Site Status

Hospital Hermanos Ameijeiras

La Habana, , Cuba

Site Status

Instituto de Oncologia Dr. Heriberto Pieter

Santo Domingo, , Dominican Republic

Site Status

Grupo Angeles

Guatemala City, , Guatemala

Site Status

Instituto Nacional de Cancerologia

Mexico City, Mexico CITY (federal District), Mexico

Site Status

Hospital Zambrano Hellion TecSalud

Monterrey, Nuevo León, Mexico

Site Status

Centro Oncologico Estatal ISSEMYM

Toluca, , Mexico

Site Status

Instituto Nacional de Enfermedades Neoplasicas

Lima, , Peru

Site Status

Clinica Internacional, Sede San Borja

Lima, , Peru

Site Status

Aliada Centro Oncologico

Lima, , Peru

Site Status

Sanatorio CASMU

Montevideo, , Uruguay

Site Status

Countries

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Argentina Brazil Chile Colombia Cuba Dominican Republic Guatemala Mexico Peru Uruguay

Other Identifiers

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MO39485

Identifier Type: -

Identifier Source: org_study_id

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