A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America

Overview

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.

Full Title of Study: “A STUDY TO OBSERVE PATIENTS CHARACTERISTICS, TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER IN LATIN AMERICA”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 28, 2025

Interventions

  • Drug: 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.
  • Drug: 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.
  • Drug: 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.
  • Drug: 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.
  • Drug: 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.
  • Drug: 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants with Different Breast Cancer Subtypes at Diagnosis in Latin America
    • Time Frame: Baseline up to 12 months

Secondary Measures

  • Percentage of Participants with Pathological Complete Response (pCR defined ypT0/is, N0)
    • Time Frame: Baseline up to approximately 6 years
  • Percentage of Participants with Locoregional Recurrence (LRR)
    • Time Frame: Baseline up to approximately 6 years
  • Percentage of Participants with Event Free Survival (EFS)
    • Time Frame: Baseline up to approximately 6 years
  • Percentage of Participants with Invasive Disease-Free Survival (iDFS)
    • Time Frame: Baseline up to approximately 6 years
  • Percentage of Participants with Overall Survival
    • Time Frame: Baseline up to approximately 6 years
  • Percentage of Participants with Objective Response Rate (ORR)
    • Time Frame: Baseline up to approximately 6 years
  • Percentage of Participants with Anti-Cancer Treatment Modifications
    • Time Frame: Baseline up to approximately 6 years
  • Percentage of Participants with Breast Cancer Treatment based on Different Socio-Demographics Characteristics
    • Time Frame: Baseline up to approximately 6 years
  • Percentage of Participants (During Observation Period) with Pregnancy
    • Time Frame: Baseline up to approximately 6 years
  • Percentage of Participants (during Observation Period) with Pregnancy Outcomes
    • Time Frame: Baseline up to approximately 6 years
  • Percentage of Participants with Non-Serious Adverse Events of Special Interests
    • Time Frame: Baseline up to approximately 6 years
  • Percentage of Participants with AEs Leading to Discontinuation or Dose Modification
    • Time Frame: Baseline up to approximately 6 years
  • Percentage of Participants with Cardiac Safety Events
    • Time Frame: Baseline up to approximately 6 years
  • Percentage of Participants Adherent to Predefined Clinical Guideliens Regarding Anti-Cancer Treatment Regimens
    • Time Frame: Baseline up to approximately 6 years
  • Percentage of Partcipants with Access to Biomarker Testing and Diagnostic Methods
    • Time Frame: Baseline up to approximately 6 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Hoffmann-La Roche
  • Collaborator
    • Latin American Cooperative Oncology Group
  • Provider of Information About this Clinical Study
    • Sponsor

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