Clinical trial · Observational
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
NCT05000736CI-TRIAL-00058148CAPACITYunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Receptor Positive Advanced Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fulvestrant | Drug | Fulvestrant | ALIAS |
| palbociclib + aromatase inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- palbociclib + aromatase inhibitor
- description
- Adult patients with HR+/HER2- advanced breast cancer who received the initial endocrine therapy of palbociclib plus aromatase inhibitor at the Cancer Hospital Chinese Academy of Medical Sciences from August 1, 2018 to December 31, 2020.
- interventionNames
- Drug: palbociclib + aromatase inhibitor
- label
- fulvestrant
- description
- Adult patients with HR+/HER2- advanced breast cancer who received the initial endocrine therapy of fulvestrant monotherapy at the Cancer Hospital Chinese Academy of Medical Sciences from August 1, 2018 to December 31, 2020.
- interventionNames
- Drug: fulvestrant
Primary outcomes (1)
- measure
- Real-world progression-free survival (rwPFS)
- timeFrame
- From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Chinese women ≥18 years old; 2. Diagnosed with locally advanced (stage IIIb/IIIc) or metastatic (stage IV) breast cancer; 3. The molecular classification is pathologically confirmed as HR+/HER2-; 4. Palbociclib plus AI or fulvestrant monotherapy as initial endocrine therapy for advanced breast cancer for at least 1 cycle; 5. The follow-up time should be not less than 3 months after the start of palbociclib plus AI therapy or fulvestrant monotherapy. Exclusion Criteria: 1\. Subjects who have previously received chemotherapy, other CDK4/6 inhibitors or other endocrine monotherapy for advanced breast cancer.
References
Publications (0)
Data not yet available
No reference posted for this study.