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.
Study Type
OBSERVATIONAL
Enrollment
200
Research Site
Fortaleza, Brazil
RECRUITINGResearch Site
Porto Alegre, Brazil
RECRUITINGResearch Site
Salvador, Brazil
RECRUITINGNumber of patients by drug class and treatment line
The proportion of HR-positive/HER2-negative patients receiving each drug class in each line of treatment
Time frame: through study completion, an average of 1 year"
Indicate demographic of these patients
Demographic profile: age, gender, ethnicity, family history of BC
Time frame: through study completion, an average of 1 year"
Indicate pathological characteristics of these patients
Clinic-pathological profile: ECOG, staging, histological type, sites of metastasis, genetic alterations, early breast cancer treatments, comorbidities, menopausal status, description of HER2 testing
Time frame: through study completion, an average of 1 year"
AstraZeneca Clinical Study Information Center
CONTACT
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Research Site
São Paulo, Brazil
RECRUITING