ClinicalTrials.gg
CompletedNCT04158258Updated Aug 17, 2026

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

An observational study in Breast Cancer, sponsored by Hoffmann-La Roche. Completed at 30 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,907
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's enrollment of 2,907 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,907 participants (actual)
Patient registry
No

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.

    Drug: Bevacizumab

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • 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.

    Also known as: Avastin

  • 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.

    Also known as: Herceptin

  • 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.

    Also known as: Kadcyla

  • 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.

    Also known as: Perjeta

  • 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.

    Also known as: Tecentriq

  • 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.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants with Different Breast Cancer Subtypes at Diagnosis in Latin America

    Time frame: Baseline up to 12 months

Secondary outcomes

  1. Percentage of Participants with Pathological Complete Response (pCR defined ypT0/is, N0)

    Time frame: Baseline up to approximately 6 years

  2. Percentage of Participants with Locoregional Recurrence (LRR)

    Time frame: Baseline up to approximately 6 years

  3. Percentage of Participants with Event Free Survival (EFS)

    Time frame: Baseline up to approximately 6 years

  4. Percentage of Participants with Invasive Disease-Free Survival (iDFS)

    Time frame: Baseline up to approximately 6 years

  5. Percentage of Participants with Overall Survival

    Time frame: Baseline up to approximately 6 years

  6. Percentage of Participants with Objective Response Rate (ORR)

    Time frame: Baseline up to approximately 6 years

  7. Percentage of Participants with Anti-Cancer Treatment Modifications

    Time frame: Baseline up to approximately 6 years

  8. Percentage of Participants with Breast Cancer Treatment based on Different Socio-Demographics Characteristics

    Time frame: Baseline up to approximately 6 years

  9. Percentage of Participants (During Observation Period) with Pregnancy

    Time frame: Baseline up to approximately 6 years

  10. Percentage of Participants (during Observation Period) with Pregnancy Outcomes

    Time frame: Baseline up to approximately 6 years

  11. Percentage of Participants with Non-Serious Adverse Events of Special Interests

    Time frame: Baseline up to approximately 6 years

  12. Percentage of Participants with AEs Leading to Discontinuation or Dose Modification

    Time frame: Baseline up to approximately 6 years

  13. Percentage of Participants with Cardiac Safety Events

    Time frame: Baseline up to approximately 6 years

  14. Percentage of Participants Adherent to Predefined Clinical Guideliens Regarding Anti-Cancer Treatment Regimens

    Time frame: Baseline up to approximately 6 years

  15. Percentage of Partcipants with Access to Biomarker Testing and Diagnostic Methods

    Time frame: Baseline up to approximately 6 years

07

Study locations

30 sites
  • Instituto Alexander Fleming
    Buenos Aires, 1426, Argentina
  • Instituto Oncologico De Cordoba
    Córdoba, 5000, Argentina
  • Hospital Privado Centro Medico de Cordoba
    Córdoba, 5016, Argentina
  • Hospital de Morón
    Morón, Argentina
  • Instituto de Oncología de Rosario
    Rosario, S2000KZE, Argentina
  • Sanatorio de la Mujer
    Rosario, S2000ORE, Argentina
  • Crio - Centro Regional Integrado de Oncologia
    Fortaleza, Ceará 60336-550, Brazil
  • Hospital do Câncer de Londrina
    Londrina, Paraná 86015-520, Brazil
  • Hospital Jardim Amália
    Volta Redonda, Rio de Janeiro 27251-260, Brazil
  • Inst. de Vita
    Caxias do Sul, Rio Grande do Sul 95020-450, Brazil
  • Centro de Pesquisa em Oncologia
    Porto Alegre, Rio Grande do Sul 90840-440, Brazil
  • Instituto Nacional de Cancer - INCa
    Rio de Janeiro, 20560-120, Brazil
  • Instituto Brasileiro De Controle Do Câncer - IBCC
    São Paulo, 03102-002, Brazil
  • Clinica Las Condes
    Santiago, 7591046, Chile
  • Instituto Nacional del Cancer
    Santiago, 8380000, Chile
  • Hospital Dr. Hernan Henriquez Aravena
    Temuco, 4781151, Chile
  • Organización Clínica Bonnadona Prevenir S.A.S
    Barranquilla, Colombia
  • Inst. Nacional de Cancerologia
    Bogotá, Colombia
  • Centro Medico Imbanaco
    Cali, Colombia
  • Fundacion Cardiovascular de Colombia - Instituto del Corazón
    Floridablanca, Colombia
  • Hospital Hermanos Ameijeiras
    La Habana, 10300, Cuba
  • Instituto de Oncologia Dr. Heriberto Pieter
    Santo Domingo, 10150, Dominican Republic
  • Grupo Angeles
    Guatemala City, 01015, Guatemala
  • Instituto Nacional de Cancerologia
    Mexico City, Mexico CITY (federal District) 14080, Mexico
  • Hospital Zambrano Hellion TecSalud
    Monterrey, Nuevo León, Mexico
  • Centro Oncologico Estatal ISSEMYM
    Toluca, 50180, Mexico
  • Instituto Nacional de Enfermedades Neoplasicas
    Lima, 15038, Peru
  • Clinica Internacional, Sede San Borja
    Lima, Lima 41, Peru
  • Aliada Centro Oncologico
    Lima, Peru
  • Sanatorio CASMU
    Montevideo, Uruguay
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04158258
Lead sponsor
Hoffmann-La Roche
Collaborators
Latin American Cooperative Oncology Group
Responsible party
Sponsor
First posted
Nov 8, 2019
Start date
Feb 21, 2020
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026
Last update
Aug 17, 2026

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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