Trials / Unknown
UnknownNCT05000736
Comparative Effectiveness of Palbociclib Plus AI Versus Fulvestrant for HR+/HER2- ABC
Comparative Effectiveness of Palbociclib Plus Aromatase Inhibitor Versus Fulvestrant Alone as Initial Endocrine Therapy for HR+/HER2- Advanced Breast Cancer in Chinese Clinical Practice: a Real-world Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (estimated)
- Sponsor
- Chinese Academy of Medical Sciences · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A retrospective cohort study conducted at the Cancer Hospital Chinese Academy of Medical Sciences to compare the effectiveness of palbociclib plus AI therapy and fulvestrant monotherapy as initial endocrine therapy in the patients with HR+/HER2- advanced breast cancer.
Detailed description
This study is designed to be a retrospective cohort study conducted at the Cancer Hospital Chinese Academy of Medical Sciences. The target populations of this study are patients with HR+/HER2- advanced breast cancer who received the initial endocrine therapy of palbociclib plus AI or fulvestrant monotherapy from August 1, 2018 to December 31, 2020. It is expected to enroll 600 subjects in this study. The subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected retrospectively, and statistical analysis of data will be conducted to compare the effectiveness outcome measures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | palbociclib + aromatase inhibitor | palbociclib + aromatase inhibitor therapy |
| DRUG | fulvestrant | fulvestrant monotherapy |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2022-09-01
- Completion
- 2022-09-01
- First posted
- 2021-08-11
- Last updated
- 2022-04-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05000736. Inclusion in this directory is not an endorsement.