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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT01380808
Eligibility Criteria:
Inclusion Criteria:
1. Female between 18 and 70 years old
2. Patients with histologic proved metastatic breast cancer, unsuitable to be treated locally.
3. Patients with Her-2 negative breast cancer(HER-2 negative or one plus by IHC test , if HER-2 two plus by IHC,FISH result should be negative)
4. Disease progression after anthracycline and/or taxane regimen therapy and candidate for capecitabine monotherapy
5. Patients previously treated by capecitabine containing regimen should response to the chemotherapy containing capecitabine and progressed at least 4 months after the last capecitabine treatment
6. Karnofsky score more than 70；ECOG 0\~2；
7. Normal functions with heart, liver,renal and bone marrow
8. WBC≥4×109/L；Hb≥90 g/L；plt≥100×109/L
9. Got ICF before enrollment
Exclusion Criteria:
1. Pregnant or breast-feeding women or positive serum pregnancy test
2. Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling
3. Participation in any investigational drug study within 4 weeks preceding treatment start.
4. Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer.
5. Serious uncontrolled intercurrent infections
6. Poor compliance
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01380808
Study Brief:
Protocol Section:
NCT01380808