The goal of this observational study is to learn about the safety and effectiveness of people with advanced breast cancer that is hormone receptor-positive (HR+), HER2-negative (HER2-). Participants will: Allow researchers to collect medical data during routine care Be followed for signs of treatment effectiveness and any medical problems that happen while taking the drug
Study Type
OBSERVATIONAL
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Incidence of Adverse Events (AEs)
The number and percentage of participants who experience any adverse event (AE) during treatment, regardless of severity or causality. Events will be coded using standard terminology (e.g., MedDRA).
Time frame: From first dose until 30 days after last dose or end of follow-up (approximately 6 to 12 months)
Incidence of Serious Adverse Events (SAEs)
The number and percentage of participants who experience any serious adverse event (SAE), defined per ICH-GCP and local regulatory standards.
Time frame: From first dose until 30 days after last dose or end of follow-up
Rate of Dose Modifications Due to Adverse Events
The number and percentage of participants who require dose reductions or interruptions due to treatment-related adverse events.
Time frame: From Day 1 (first dose) through the end of treatment (up to 24 months)
Rate of Discontinuation Due to Adverse Events
The number and percentage of participants who permanently stop treatment due to treatment-related adverse events.
Time frame: From Day 1 (first dose) through the end of treatment (up to 24 months)
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