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

A STUDY TO OBSERVE PATIENTS CHARACTERISTICS, TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER IN LATIN AMERICA

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Bevacizumab; Drug: Trastuzumab; Drug: Ado-trastuzumab emtamsine; Drug: Pertuzumab; Drug: Atezolizumab; Drug: Capecitabine

• Study Type: Observational
• Enrollment (Actual): 2907

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1426
    • Instituto Alexander Fleming
  • Córdoba, Argentina, 5016
    • Hospital Privado Centro Medico de Cordoba
  • Córdoba, Argentina, 5000
    • Instituto Oncologico de Cordoba
  • Morón, Argentina
    • Hospital de Morón
  • Rosario, Argentina, S2000KZE
    • Instituto de Oncología de Rosario
  • Rosario, Argentina, S2000ORE
    • Sanatorio de la Mujer
• Brazil
  • Rio de Janeiro, Brazil, 20560-120
    • Instituto Nacional de Cancer - INCa
  • São Paulo, Brazil, 03102-002
    • Instituto Brasileiro De Controle Do Câncer - IBCC
  • Ceará
    • Fortaleza, Ceará, Brazil, 60336-550
      • Crio - Centro Regional Integrado de Oncologia
  • Paraná
    • Londrina, Paraná, Brazil, 86015-520
      • Hospital do Câncer de Londrina
  • Rio Grande do Sul
    • Caxias do Sul, Rio Grande do Sul, Brazil, 95020-450
      • Inst. de Vita
    • Porto Alegre, Rio Grande do Sul, Brazil, 90840-440
      • Centro de Pesquisa em Oncologia
  • Rio de Janeiro
    • Volta Redonda, Rio de Janeiro, Brazil, 27251-260
      • Hospital Jardim Amália
• Chile
  • Santiago, Chile, 8380000
    • Instituto Nacional del Cancer
  • Santiago, Chile, 7591046
    • Clinica Las Condes
  • Temuco, Chile, 4781151
    • Hospital Dr. Hernán Henríquez Aravena
• Colombia
  • Barranquilla, Colombia
    • Organización Clínica Bonnadona Prevenir S.A.S
  • Bogotá, Colombia
    • Inst. Nacional de Cancerologia
  • Cali, Colombia
    • Centro Médico Imbanaco
  • Floridablanca, Colombia
    • Fundacion Cardiovascular de Colombia - Instituto del Corazón
• Cuba
  • La Habana, Cuba, 10300
    • Hospital Hermanos Ameijeiras
• Dominican Republic
  • Santo Domingo, Dominican Republic, 10150
    • Instituto de Oncologia Dr. Heriberto Pieter
• Guatemala
  • Guatemala City, Guatemala, 01015
    • Grupo Angeles
• Mexico
  • Toluca, Mexico, 50180
    • Centro Oncologico Estatal ISSEMYM
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 14080
      • Instituto Nacional de Cancerologia
  • Nuevo León
    • Monterrey, Nuevo León, Mexico
      • Hospital Zambrano Hellion TecSalud
• Peru
  • Lima, Peru
    • Aliada Centro Oncologico
  • Lima, Peru, 15038
    • Instituto Nacional de Enfermedades Neoplasicas
  • Lima, Peru, Lima 41
    • Clinica Internacional, Sede San Borja
• Uruguay
  • Montevideo, Uruguay
    • Sanatorio CASMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The patients will be recruited from approximately 10 countries and from a variety of healthcare sites (ex: specialty care, private practice, teaching institution, etc.)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: 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.; Other Names: Avastin
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: 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.; Other Names: Herceptin
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: 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.; Other Names: Kadcyla
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: 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.; Other Names: Perjeta
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: 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.; Other Names: Tecentriq
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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Latin American Cooperative Oncology Group
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Polycyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Macrolides; Lactones; Nucleosides; Uracil; Pyrimidinones; Lactams, Macrocyclic; Macrocyclic Compounds; Deoxyribonucleosides; Fluorouracil; Maytansine; Trastuzumab; Capecitabine; Bevacizumab; Ado-Trastuzumab Emtansine; pertuzumab; atezolizumab
• Other Study ID Numbers: MO39485

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO