Breast Cancer
Conditions
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.
Interventions
DRUGBevacizumab
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.
DRUGTrastuzumab
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.
DRUGAdo-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.
DRUGPertuzumab
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.
DRUGAtezolizumab
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.
DRUGCapecitabine
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.
Sponsors
Hoffmann-La Roche
Latin American Cooperative Oncology Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Different Breast Cancer Subtypes at Diagnosis in Latin America | Baseline up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 Breast Cancer Treatment based on Different Socio-Demographics Characteristics | 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 Non-Serious Adverse Events of Special Interests | Baseline up to approximately 6 years |
| Percentage of Participants with AEs Leading to Discontinuation or Dose Modification | 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 |
| Percentage of Partcipants with Access to Biomarker Testing and Diagnostic Methods | Baseline up to approximately 6 years |
Countries
Argentina, Brazil, Chile, Colombia, Cuba, Dominican Republic, Guatemala, Mexico, Peru, Uruguay
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed