A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT04158258
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2907
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ado-trastuzumab emtamsine 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. Atezolizumab 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 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. Bevacizumab 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 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. Pertuzumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Different Breast Cancer Subtypes at Diagnosis in Latin America Baseline up to 12 months
- Secondary Outcome Measures
Name Time Method Percentage of Participants with AEs Leading to Discontinuation or Dose Modification Baseline up to approximately 6 years Percentage of Participants with Event Free Survival (EFS) Baseline up to approximately 6 years Percentage of Participants with Breast Cancer Treatment based on Different Socio-Demographics Characteristics Baseline up to approximately 6 years Percentage of Participants with Pathological Complete Response (pCR defined ypT0/is, N0) Baseline up to approximately 6 years Percentage of Participants with Invasive Disease-Free Survival (iDFS) Baseline up to approximately 6 years Percentage of Participants (During Observation Period) with Pregnancy Baseline up to approximately 6 years Percentage of Participants (during Observation Period) with Pregnancy Outcomes Baseline up to approximately 6 years Percentage of Participants with Locoregional Recurrence (LRR) Baseline up to approximately 6 years Percentage of Participants with Overall Survival Baseline up to approximately 6 years Percentage of Participants with Objective Response Rate (ORR) Baseline up to approximately 6 years Percentage of Participants with Anti-Cancer Treatment Modifications Baseline up to approximately 6 years Percentage of Participants with Non-Serious Adverse Events of Special Interests Baseline up to approximately 6 years Percentage of Partcipants with Access to Biomarker Testing and Diagnostic Methods Baseline up to approximately 6 years Percentage of Participants with Cardiac Safety Events Baseline up to approximately 6 years Percentage of Participants Adherent to Predefined Clinical Guideliens Regarding Anti-Cancer Treatment Regimens Baseline up to approximately 6 years
Trial Locations
- Locations (30)
Instituto Brasileiro De Controle Do CĂ¢ncer - IBCC
đŸ‡§đŸ‡·SĂ£o Paulo, Brazil
Sanatorio de la Mujer
đŸ‡¦đŸ‡·Rosario, Argentina
Hospital Jardim AmĂ¡lia
đŸ‡§đŸ‡·Volta Redonda, Rio De Janeiro, Brazil
Inst. de Vita
đŸ‡§đŸ‡·Caxias do Sul, Rio Grande Do Sul, Brazil
Grupo Angeles
đŸ‡¬đŸ‡¹Guatemala City, Guatemala
Instituto Nacional de Cancerologia
đŸ‡²đŸ‡½Mexico City, Mexico CITY (federal District), Mexico
Aliada Centro Oncologico
đŸ‡µđŸ‡ªLima, Peru
Fundacion Cardiovascular de Colombia - Instituto del CorazĂ³n
đŸ‡¨đŸ‡´Floridablanca, Colombia
Inst. Nacional de Cancerologia
đŸ‡¨đŸ‡´Bogota, Colombia
Clinica Internacional, Sede San Borja
đŸ‡µđŸ‡ªLima, Peru
Instituto de OncologĂa de Rosario
đŸ‡¦đŸ‡·Rosario, Argentina
Instituto Nacional del Cancer
đŸ‡¨đŸ‡±Santiago, Chile
Centro Medico Imbanaco
đŸ‡¨đŸ‡´Cali, Colombia
Instituto Oncologico De Cordoba
đŸ‡¦đŸ‡·Cordoba, Argentina
Hospital Hermanos Ameijeiras
đŸ‡¨đŸ‡ºLa Habana, Cuba
Instituto de Oncologia Dr. Heriberto Pieter
đŸ‡©đŸ‡´Santo Domingo, Dominican Republic
Instituto Nacional de Cancer - INCa
đŸ‡§đŸ‡·Rio de Janeiro, Brazil
Sanatorio CASMU
đŸ‡ºđŸ‡¾Montevideo, Uruguay
Hospital Privado Centro Medico de Cordoba
đŸ‡¦đŸ‡·CĂ³rdoba, Argentina
Hospital de MorĂ³n
đŸ‡¦đŸ‡·Moron, Argentina
Crio - Centro Regional Integrado de Oncologia
đŸ‡§đŸ‡·Fortaleza, CearĂ¡, Brazil
Hospital do CĂ¢ncer de Londrina
đŸ‡§đŸ‡·Londrina, ParanĂ¡, Brazil
Centro de Pesquisa em Oncologia
đŸ‡§đŸ‡·Porto Alegre, Rio Grande Do Sul, Brazil
Centro Oncologico Estatal ISSEMYM
đŸ‡²đŸ‡½Toluca, Mexico
Instituto Alexander Fleming
đŸ‡¦đŸ‡·Buenos Aires, Argentina
Clinica Las Condes
đŸ‡¨đŸ‡±Santiago, Chile
Hospital Dr. Hernan Henriquez Aravena
đŸ‡¨đŸ‡±Temuco, Chile
OrganizaciĂ³n ClĂnica Bonnadona Prevenir S.A.S
đŸ‡¨đŸ‡´Barranquilla, Colombia
Hospital Zambrano Hellion TecSalud
đŸ‡²đŸ‡½Monterrey, Nuevo LEON, Mexico
Instituto Nacional de Enfermedades Neoplasicas
đŸ‡µđŸ‡ªLima, Peru