A STUDY TO OBSERVE PATIENTS CHARACTERISTICS, TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER IN LATIN AMERICA
Overview
- Phase
- Not Applicable
- Intervention
- Trastuzumab
- Conditions
- Breast Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 2907
- Locations
- 51
- Primary Endpoint
- Percentage of Participants with Different Breast Cancer Subtypes at Diagnosis in Latin America
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Trastuzumab
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.
Intervention: Bevacizumab
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.
Intervention: Ado-trastuzumab emtamsine
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.
Intervention: Pertuzumab
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.
Intervention: Atezolizumab
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.
Intervention: Capecitabine
Outcomes
Primary Outcomes
Percentage of Participants with Different Breast Cancer Subtypes at Diagnosis in Latin America
Time Frame: Baseline up to 12 months
Secondary Outcomes
- 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)