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

August 13, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
      • 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 Oncologia 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. Hernan Henriquez Aravena
  • Colombia
      • Barranquilla, Colombia
        • Organización Clínica Bonnadona Prevenir S.A.S
      • Bogotá, Colombia
        • Inst. Nacional de Cancerología
      • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Latin American Cooperative Oncology Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MO39485

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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