Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy
Phase 2
Not yet recruiting
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT05979220
- Lead Sponsor
- Shuangyue Liu
- 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 chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 178
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dalpiciclib combined with Letrozole Dalpiciclib combined with Letrozole Dalpiciclib combined with Letrozole,28 days as one cycle. 1. Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle. 2. Letrozole: 2.5mg, p.o., once a day, continuous administration.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Estimated up to 23 months The time from the enrollment of the subject until the first recording of tumor progression (evaluated according to RECIST 1.1 criteria) or death from any cause.
- Secondary Outcome Measures
Name Time Method Progression Free Survival 2(PFS2) Estimated up to 27-31 months The time from the first chemotherapy for the metastatic stage by the subject to the first recording of tumor progression (evaluated according to RECIST 1.1 standards) or death from any cause.
Trial Locations
- Locations (1)
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China