Trials / Unknown
UnknownNCT03966898
A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
A Phase III Study to Evaluate Efficacy and Safety of SHR6390 in Combination With Letrozole or Anastrozole Versus Placebo in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 426 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole in Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have not received systemic anticancer therapy are eligible for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR6390 Tablets | SHR6390 Tablets |
| DRUG | Placebo Tablets | Placebo Tablets |
| DRUG | Letrozole or Anastrozole Tablets | Letrozole or Anastrozole Tablets |
Timeline
- Start date
- 2019-07-19
- Primary completion
- 2022-12-30
- Completion
- 2023-12-30
- First posted
- 2019-05-29
- Last updated
- 2021-06-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03966898. Inclusion in this directory is not an endorsement.