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Completed

NCT Number: NCT04158258

A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome 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.

Completed

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Alexander Fleming, Buenos Aires, Argentina

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

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

Drug

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

Drug

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

Drug

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

Drug

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

Drug

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.

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Latin American Cooperative Oncology Group

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2019
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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