Status:
NOT_YET_RECRUITING
Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy
Lead Sponsor:
Shuangyue Liu
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
This study aimed to evaluate the efficacy and safety of Dalpiciclib combined with Letrozole in the maintenance treatment of HR positive and HER2 negative metastatic breast cancer after first-line chem...
Eligibility Criteria
Inclusion
- Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
- Age: 18 - 75 years old
- Eastern Cooperative Oncology Group performance status (ECOG PS)=0\~1
- Functions of liver and kidney is normal
- Agreed to take contraceptive measures during treatment
Exclusion
- Confirmed diagnosis of HER2 positive disease.
- Central nervous system metastasis
- Patients who received prior treatment with any CDK4/6 inhibitor.
- Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention；
- Researchers believe that is not suitable for the study
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT05979220
Start Date
December 1 2023
End Date
June 30 2028
Last Update
August 7 2023
Active Locations (1)
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1
West China Hospital, Sichuan University
Chengdu, Sichuan, China