Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT05979220
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05979220
Study Brief:
Protocol Section:
NCT05979220