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Trial Title:
Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy
NCT ID:
NCT05979220
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Letrozole
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Dalpiciclib combined with Letrozole
Description:
A multicenter, single arm, prospective Phase II clinical study
Arm group label:
Dalpiciclib combined with Letrozole
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic,
hormone-receptor positive, HER2 negative Breast Cancer.
2. Age: 18 - 75 years old
3. Eastern Cooperative Oncology Group performance status (ECOG PS)=0~1
4. Functions of liver and kidney is normal
5. Agreed to take contraceptive measures during treatment
Exclusion Criteria:
1. Confirmed diagnosis of HER2 positive disease.
2. Central nervous system metastasis
3. Patients who received prior treatment with any CDK4/6 inhibitor.
4. 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；
5. Researchers believe that is not suitable for the study
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Country:
China
Contact:
Last name:
Ting Luo, MD
Phone:
18602866299
Phone ext:
+86
Email:
tina621@163.com
Start date:
December 1, 2023
Completion date:
June 30, 2028
Lead sponsor:
Agency:
Shuangyue Liu
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05979220
