drugset / Trial / NCT06176534
Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial
RandomizedParallel-groupOpen-labelTreatment
Summary
To observe the differences in the efficacy of Combination followed by maintenance chemotherapy versus CDK4/6 inhibitor combined with endocrine therapy in HR low expression /HER2 negative advanced breast cancer, and to provide new evidence for the best treatment of HR low expression /HER2 negative advanced breast cancer, and to explore the efficacy and safety of combined/maintenance chemotherapy.
Timeline
- Start
- 2024-01-01
- Primary completion
- 2025-12-20
- Completion
- 2026-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anastrozole | Other / unclassified | 1 mg | — |
| Subject | Capecitabine | Small molecule | 2000 mg/m2 | — |
| Comparator | Dalpiciclib | Small molecule | 150 mg | — |
| Comparator | Fulvestrant | Small molecule | 500 mg | — |
| Comparator | Letrozole | Other / unclassified | 2.5 mg | — |
| Subject | Paclitaxel | Small molecule | 130 mg/m2 | — |
| Comparator | Palbociclib | Small molecule | 125 mg | — |
| Subject | Vinorelbine | Small molecule | 25 mg/m2 | — |