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

Breast Cancer Clinical Trial

Official title:

A STUDY TO OBSERVE PATIENTS CHARACTERISTICS, TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER IN LATIN AMERICA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04158258
• Other study ID #: MO39485
• Status: Active, not recruiting
• Start date: February 21, 2020
• Est. completion date: November 28, 2025

Study information

• Verified date: February 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

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