drugset / Trial / NCT03481998
A Study of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a phase IB/II clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole or Fulvestrant. Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have not received systemic anticancer therapy are eligible for study.
Timeline
- Start
- 2018-03-22
- Primary completion
- 2022-07-30
- Completion
- 2022-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anastrozole | Other / unclassified | 1 mg | Oral |
| Subject | Dalpiciclib | Small molecule | 125 mg | Oral |
| Subject | Dalpiciclib | Small molecule | 150 mg | Oral |
| Subject | Dalpiciclib | Small molecule | 175 mg | Oral |
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Subject | Letrozole | Other / unclassified | 2.5 mg | Oral |