A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America
Active, not recruiting
- 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
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
- 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 Oncologico De Cordoba
🇦🇷Cordoba, Argentina
Instituto Nacional de Cancer - INCa
🇧🇷Rio de Janeiro, Brazil
Instituto Brasileiro De Controle Do Câncer - IBCC
🇧🇷São Paulo, Brazil
Inst. Nacional de Cancerologia
🇨🇴Bogota, Colombia
Clinica Internacional, Sede San Borja
🇵🇪Lima, Peru
Sanatorio CASMU
🇺🇾Montevideo, Uruguay
Instituto Alexander Fleming
🇦🇷Buenos Aires, Argentina
Hospital Privado Centro Medico de Cordoba
🇦🇷Córdoba, Argentina
Hospital de Morón
🇦🇷Moron, Argentina
Instituto de Oncología de Rosario
🇦🇷Rosario, Argentina
Scroll for more (20 remaining)Instituto Oncologico De Cordoba🇦🇷Cordoba, Argentina