A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America
A STUDY TO OBSERVE PATIENTS CHARACTERISTICS, TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER IN LATIN AMERICA
1 other identifier
observational
2,907
10 countries
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2019
CompletedFirst Posted
Study publicly available on registry
November 8, 2019
CompletedStudy Start
First participant enrolled
February 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
April 23, 2026
April 1, 2026
6.4 years
November 5, 2019
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with Different Breast Cancer Subtypes at Diagnosis in Latin America
Baseline up to 12 months
Secondary Outcomes (15)
Percentage of Participants with Pathological Complete Response (pCR defined ypT0/is, N0)
Baseline up to approximately 6 years
Percentage of Participants with Locoregional Recurrence (LRR)
Baseline up to approximately 6 years
Percentage of Participants with Event Free Survival (EFS)
Baseline up to approximately 6 years
Percentage of Participants with Invasive Disease-Free Survival (iDFS)
Baseline up to approximately 6 years
Percentage of Participants with Overall Survival
Baseline up to approximately 6 years
- +10 more secondary outcomes
Study Arms (6)
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.
Interventions
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.
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.
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.
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.
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.
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.
Eligibility Criteria
The patients will be recruited from approximately 10 countries and from a variety of healthcare sites (ex: specialty care, private practice, teaching institution, etc.)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Latin American Cooperative Oncology Groupcollaborator
Study Sites (30)
Instituto Alexander Fleming
Buenos Aires, 1426, Argentina
Instituto Oncologico De Cordoba
Córdoba, 5000, Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, 5016, Argentina
Hospital de Morón
Morón, Argentina
Instituto de Oncología de Rosario
Rosario, S2000KZE, Argentina
Sanatorio de la Mujer
Rosario, S2000ORE, Argentina
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336-550, Brazil
Hospital do Câncer de Londrina
Londrina, Paraná, 86015-520, Brazil
Hospital Jardim Amália
Volta Redonda, Rio de Janeiro, 27251-260, Brazil
Inst. de Vita
Caxias do Sul, Rio Grande do Sul, 95020-450, Brazil
Centro de Pesquisa em Oncologia
Porto Alegre, Rio Grande do Sul, 90840-440, Brazil
Instituto Nacional de Cancer - INCa
Rio de Janeiro, 20560-120, Brazil
Instituto Brasileiro De Controle Do Câncer - IBCC
São Paulo, 03102-002, Brazil
Clinica Las Condes
Santiago, 7591046, Chile
Instituto Nacional del Cancer
Santiago, 8380000, Chile
Hospital Dr. Hernan Henriquez Aravena
Temuco, 4781151, Chile
Organización Clínica Bonnadona Prevenir S.A.S
Barranquilla, Colombia
Inst. Nacional de Cancerologia
Bogotá, Colombia
Centro Medico Imbanaco
Cali, Colombia
Fundacion Cardiovascular de Colombia - Instituto del Corazón
Floridablanca, Colombia
Hospital Hermanos Ameijeiras
La Habana, 10300, Cuba
Instituto de Oncologia Dr. Heriberto Pieter
Santo Domingo, 10150, Dominican Republic
Grupo Angeles
Guatemala City, 01015, Guatemala
Instituto Nacional de Cancerologia
Mexico City, Mexico CITY (federal District), 14080, Mexico
Hospital Zambrano Hellion TecSalud
Monterrey, Nuevo León, Mexico
Centro Oncologico Estatal ISSEMYM
Toluca, 50180, Mexico
Instituto Nacional de Enfermedades Neoplasicas
Lima, 15038, Peru
Clinica Internacional, Sede San Borja
Lima, Lima 41, Peru
Aliada Centro Oncologico
Lima, Peru
Sanatorio CASMU
Montevideo, Uruguay
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2019
First Posted
November 8, 2019
Study Start
February 21, 2020
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share