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
Last Updated: 2023-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
178 participants
INTERVENTIONAL
2023-12-01
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Dalpiciclib combined with Letrozole
A multicenter, single arm, prospective Phase II clinical study
Interventions
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Dalpiciclib combined with Letrozole
A multicenter, single arm, prospective Phase II clinical study
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
FEMALE
No
Sponsors
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Shuangyue Liu
OTHER
Responsible Party
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Shuangyue Liu
Clinical Professor
Locations
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West China Hospital, Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OBU-SC-BC-II-015
Identifier Type: -
Identifier Source: org_study_id
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