A multi-center non-interventional observational study led by the Cancer Hospital Chinese Academy of Medical Sciences to compare the effectiveness of palbociclib based-therapy as initial endocrine therapy versus palbociclib based-therapy after chemotherapy for HR+/HER2- advanced breast cancer.
This study is designed to be a multi-center non-interventional observational study led by the Cancer Hospital Chinese Academy of Medical Sciences. The target populations of this study are patients with HR+/HER2- advanced breast cancer who received palbociclib based-therapy as initial endocrine therapy or palbociclib based-therapy after chemotherapy from August 1, 2018 to December 31, 2023. It is expected to enroll 400 subjects in this study. The subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected in a mixed manner, and statistical analysis of data will be conducted to compare the effectiveness outcome measures.
Study Type
OBSERVATIONAL
Enrollment
400
Palbociclib + aromatase inhibitor/fulvestrant (initial endocrine therapy)
Palbociclib + aromatase inhibitor/fulvestrant (after chemotherapy)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGChina-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGProgression-free survival (PFS)
It is defined as the time (months) from the start of palbociclib based-therapy to progressive disease or all-cause mortality. The progressive disease is determined by clinicians based on the results of clinical evaluation, laboratory tests, imaging or pathological examinations. Patients who have not died or have not experienced progressive disease will be censored at the beginning of next-line treatment or at the last visit during the study period.
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
Objective response rate (ORR)
ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) reported by doctors among all patients with response data available.
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
Disease control rate (DCR)
DCR is defined as the proportion of patients who have reached CR, PR, or stable disease (SD) reported by the doctors among all patients with response data available.
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
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