Study identifier:D9673R00053
ClinicalTrials.gov identifier:NCT06676436
EudraCT identifier:N/A
CTIS identifier:N/A
Real World outcomes and treatment patterns in Brazilian patients with hormone receptor positive / HER2-negative unresectable or metastatic breast cancer
cancer
Phase 4
No
-
Female
200
Observational
18 Years - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
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.
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.
Location
Status
Location
São Paulo, Brazil
Status
Recruiting
Location
Porto Alegre, Brazil
Status
Recruiting
Location
Salvador, Brazil
Status
Recruiting
Location
Fortaleza, Brazil
Status
Recruiting
Location
São Paulo, Brazil
Status
Not yet recruiting
Arms | Assigned Interventions |
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