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

February 12, 2024 updated by: Hoffmann-La Roche

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2907

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1426
        • Instituto Alexander Fleming
      • Cordoba, Argentina, X5016KEH
        • Hospital Privado Centro Medico de Cordoba
      • Cordoba, Argentina, 5000
        • Instituto Oncologico De Cordoba; Oncology
      • Moron, Argentina
        • Hospital de Morón
      • Rosario, Argentina, S2000KZE
        • Instituto De Oncologia De Rosario
      • Rosario, Argentina, S2000ORE
        • Sanatorio de la Mujer
  • Brazil
    • CE
      • Fortaleza, CE, Brazil, 60336-232
        • Crio - Centro Regional Integrado de Oncologia
    • PR
      • Londrina, PR, Brazil, 86015-520
        • Hospital do Cancer de Londrina
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20560-120
        • Instituto Nacional de Cancer - INCa; Oncologia
      • Volta Redonda, RJ, Brazil, 27251-260
        • Hospital Jardim Amália
    • RS
      • Caxias do Sul, RS, Brazil, 95020-450
        • Inst. de Vita
      • Porto Alegre, RS, Brazil, 90840-440
        • Centro de Pesquisa em Oncologia
    • SP
      • São Paulo, SP, Brazil, 03102-002
        • Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia
  • Chile
      • Santiago, Chile, 8380000
        • Instituto Nacional del Cancer
      • Santiago, Chile, 7591046
        • Clinica Las Condes
      • Temuco, Chile, 4781151
        • Hospital Dr. Hernan Henriquez Aravena
  • Colombia
      • Barranquilla, Colombia
        • Organización Clínica Bonnadona Prevenir S.A.S
      • Bogota, Colombia, 111511
        • Inst. Nacional de Cancerologia; Clinica de Seno
      • Cali, Colombia
        • Centro Medico Imbanaco
      • Floridablanca, Colombia
        • Fundacion Cardiovascular de Colombia - Instituto del Corazón
  • Cuba
      • La Habana, Cuba, 10300
        • Hospital Hermanos Ameijeiras
  • Dominican Republic
      • Santo Domingo, Dominican Republic
        • 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 LEON
      • Monterrey, Nuevo LEON, Mexico, 66278
        • Hospital Zambrano Hellion TecSalud
  • Peru
      • Lima, Peru, Lima 41
        • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
      • Lima, Peru, Lima 34
        • Instituto Nacional de Enfermedades Neoplasicas
      • Lima, Peru
        • Aliada Centro Oncologico
  • Uruguay
      • Montevideo, Uruguay
        • Sanatorio CASMU; Oncología

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: Baseline up to 12 months
Baseline up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Pathological Complete Response (pCR defined ypT0/is, N0)
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Percentage of Participants with Locoregional Recurrence (LRR)
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Percentage of Participants with Event Free Survival (EFS)
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Percentage of Participants with Invasive Disease-Free Survival (iDFS)
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Percentage of Participants with Overall Survival
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Percentage of Participants with Objective Response Rate (ORR)
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Percentage of Participants with Anti-Cancer Treatment Modifications
Time Frame: Baseline up to approximately 6 years
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
Baseline up to approximately 6 years
Percentage of Participants (During Observation Period) with Pregnancy
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Percentage of Participants (during Observation Period) with Pregnancy Outcomes
Time Frame: Baseline up to approximately 6 years
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
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
Baseline up to approximately 6 years
Percentage of Participants with Cardiac Safety Events
Time Frame: Baseline up to approximately 6 years
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
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
Baseline up to approximately 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

Latin American Cooperative Oncology Group

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2020

Primary Completion (Estimated)

November 28, 2025

Study Completion (Estimated)

November 28, 2025

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 (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO39485

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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