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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04158258
Other study ID # MO39485
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 21, 2020
Est. completion date November 28, 2025

Study information

Verified date May 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2907
Est. completion date November 28, 2025
Est. primary completion date November 28, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.
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.
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.
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.
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.
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.

Locations

Country Name City State
Argentina Instituto Alexander Fleming Buenos Aires
Argentina Hospital Privado Centro Medico de Cordoba Cordoba
Argentina Instituto Oncologico De Cordoba; Oncology Cordoba
Argentina Hospital de Morón Moron
Argentina Instituto de Oncología de Rosario Rosario
Argentina Sanatorio de la Mujer Rosario
Brazil Inst. de Vita Caxias do Sul RS
Brazil Crio - Centro Regional Integrado de Oncologia Fortaleza CE
Brazil Hospital do Câncer de Londrina Londrina PR
Brazil Centro de Pesquisa em Oncologia Porto Alegre RS
Brazil Instituto Nacional de Cancer - INCa; Oncologia Rio de Janeiro RJ
Brazil Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia São Paulo SP
Brazil Hospital Jardim Amália Volta Redonda RJ
Chile Clinica Las Condes Santiago
Chile Instituto Nacional del Cancer Santiago
Chile Hospital Dr. Hernan Henriquez Aravena Temuco
Colombia Organización Clínica Bonnadona Prevenir S.A.S Barranquilla
Colombia Inst. Nacional de Cancerologia; Clinica de Seno Bogota
Colombia Centro Medico Imbanaco Cali
Colombia Fundacion Cardiovascular de Colombia - Instituto del Corazón Floridablanca
Cuba Hospital Hermanos Ameijeiras La Habana
Dominican Republic Instituto de Oncologia Dr. Heriberto Pieter Santo Domingo
Guatemala Grupo Angeles Guatemala City
Mexico Instituto Nacional de Cancerologia Mexico City Mexico CITY (federal District)
Mexico Hospital Zambrano Hellion TecSalud Monterrey Nuevo LEON
Mexico Centro Oncologico Estatal ISSEMYM Toluca
Peru Aliada Centro Oncologico Lima
Peru Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional Lima
Peru Instituto Nacional de Enfermedades Neoplasicas Lima
Uruguay Sanatorio CASMU; Oncología Montevideo

Sponsors (2)

Lead Sponsor Collaborator
Hoffmann-La Roche Latin American Cooperative Oncology Group

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  Colombia,  Cuba,  Dominican Republic,  Guatemala,  Mexico,  Peru,  Uruguay, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Different Breast Cancer Subtypes at Diagnosis in Latin America Baseline up to 12 months
Secondary Percentage of Participants with Pathological Complete Response (pCR defined ypT0/is, N0) Baseline up to approximately 6 years
Secondary Percentage of Participants with Locoregional Recurrence (LRR) Baseline up to approximately 6 years
Secondary Percentage of Participants with Event Free Survival (EFS) Baseline up to approximately 6 years
Secondary Percentage of Participants with Invasive Disease-Free Survival (iDFS) Baseline up to approximately 6 years
Secondary Percentage of Participants with Overall Survival Baseline up to approximately 6 years
Secondary Percentage of Participants with Objective Response Rate (ORR) Baseline up to approximately 6 years
Secondary Percentage of Participants with Anti-Cancer Treatment Modifications Baseline up to approximately 6 years
Secondary Percentage of Participants with Breast Cancer Treatment based on Different Socio-Demographics Characteristics Baseline up to approximately 6 years
Secondary Percentage of Participants (During Observation Period) with Pregnancy Baseline up to approximately 6 years
Secondary Percentage of Participants (during Observation Period) with Pregnancy Outcomes Baseline up to approximately 6 years
Secondary Percentage of Participants with Non-Serious Adverse Events of Special Interests Baseline up to approximately 6 years
Secondary Percentage of Participants with AEs Leading to Discontinuation or Dose Modification Baseline up to approximately 6 years
Secondary Percentage of Participants with Cardiac Safety Events Baseline up to approximately 6 years
Secondary Percentage of Participants Adherent to Predefined Clinical Guideliens Regarding Anti-Cancer Treatment Regimens Baseline up to approximately 6 years
Secondary Percentage of Partcipants with Access to Biomarker Testing and Diagnostic Methods Baseline up to approximately 6 years
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