NCT06676436

Observational Study on the Treatment of Patients With Metastatic Breast Cancer

Real World Outcomes and Treatment Patterns in Brazilian Patients With Hormone Receptor Positive / HER2-negative Unresectable or Metastatic Breast Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 204 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a descriptive, retrospective, observational study to generate Real-World Evidence (RWE). This study will evaluate the treatment patterns and outcomes with metastatic or unresectable hormone receptor-positive breast cancer in Brazil. No hypotheses will be tested.

Detailed description

This project aims to understand treatment patterns and outcomes in individuals with hormone receptor-positive \[HR-positive will be defined as Estrogen Receptor (ER) ≥ 1%\] and HER2-negative (HER2-Negative will be defined as IHC 0, 1+ and 2+/ISH-) unresectable or metastatic breast cancer (mBC) in Brazil. Ten Brazilian centers will participate. This study will consist of a convenience cohort; will be included 200 patients. Adult patients who had received treatment in the participant Brazilian centers, with mBC ER-positive (i.e. ER ≥ 1%) and HER2-negative (i.e. HER2 IHC 0, 1 or 2+ with negative ISH), and who had received any CDK4/6i as first-line treatment with any outcome (death, progressive disease, or drug interruption due to any cause) since January 2018 will be enrolled. Data will be extracted from digital charts of Brazilian participating institutions. Patients who were treated with a CDK4/6i since January 2018 will be enrolled.

Conditions

• Cancer

Timeline

• Start date: 2024-11-30
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-11-06
• Last updated: 2026-02-18

Locations

4 sites across 1 country: Brazil