drugset / Trial / NCT06656624
Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequential Endocrine Therapy in ER Middle-low-expression/HER2-negative Advanced Breast Cancer (Rachel)
Phase 2
Recruiting
190 enrolled
The First Affiliated Hospital with Nanjing Medical University
Affiliated Hospital of Jiangnan University · collabThe Affiliated Jiangyin Hospital of Southeast University Medical College · collabYidu Central Hospital of Weifang · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
To compare the efficacy and safety of ribociclib in combination with aromatase inhibitor and physician's choice of chemotherapy sequential endocrine therapy in the first-line treatment of ER medium to low expression/HER2-negative advanced breast cancer.
Timeline
- Start
- 2024-08-13
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Docetaxel | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 150 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Subject | Ribociclib | Small molecule | 600 mg | Oral |
| Background | Anastrozole | Other / unclassified | 1 mg | Oral |
| Background | Exemestane | Small molecule | 25 mg | Oral |
| Background | Goserelin | Other / unclassified | 3.6 mg | Subcutaneous |
| Background | Letrozole | Other / unclassified | 2.5 mg | Oral |