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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT05673694
Eligibility Criteria:
Inclusion Criteria:
1. Female, 18-75 years old;
2. Expected survival ≥ 12 weeks;
3. Subjects with ECOG score of physical state 0\~1;
4. Histologically confirmed recurrent or metastatic advanced breast cancer;
Exclusion Criteria:
1. Those who have had a severe allergic reaction to any drug or its components in this study in the past;
2. Present with primary central nervous system (CNS) malignancies; Subjects with CNS metastasis who have failed local treatment (except asymptomatic BMS, or symptomatic BMS with complete remission of symptoms ≥ 2 weeks after treatment for BMS);
3. Has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period;
4. Gastrointestinal disorders or gastrointestinal diseases will significantly affect the absorption of test drugs (such as ulcerative disease, uncontrolled vomiting, diarrhea, malabsorption syndrome, biliary drainage status, etc.), or subjects cannot take drugs orally:
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05673694
Study Brief:
Protocol Section:
NCT05673694