NCT05343117

Comparative Effectiveness of PAL Based-therapy as Initial ET Versus PAL Based-therapy After ChT for HR+/HER2- ABC

Comparative Effectiveness of Palbociclib Based-therapy as Initial Endocrine Therapy Versus Palbociclib Based-therapy After Chemotherapy for HR+/HER2- Advanced Breast Cancer in Chinese Clinical Practice: a Real-world Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hormone Receptor Positive Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Palbociclib based-therapy as initial endocrine therapy	Palbociclib + aromatase inhibitor/fulvestrant (initial endocrine therapy)
DRUG	Palbociclib based-therapy after chemotherapy	Palbociclib + aromatase inhibitor/fulvestrant (after chemotherapy)

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-31
• Completion: 2024-06-01
• First posted: 2022-04-25
• Last updated: 2022-04-26

Locations

9 sites across 1 country: China