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:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT00717951
Eligibility Criteria:
Inclusion Criteria:
* age≥18y
* KPS≥ 70
* pathologic diagnosis of breast cancer
* at least 1 measurable lesion as defined by modified RECIST criteria
* screening laboratory values with the following parameters: hemoglobin:≥10.0 g/dl absolute neutrophils count:≥1.5×109/L platelet:≥100×109/L creatinine clearance rate: ≥60ml/min total bilirubin: ≤1.5 ×upper limits of normal Alkaline phosphatase,Aspartate aminotransferase and Alanine aminotransferase:≤ 2.5×upper limits of normal（≤5×upper limits of normal if liver metastasis are present)
* signed ICF
* for women of child bearing potential,a negative serum or urine pregnancy test result before study entry.
Exclusion Criteria:
* More than 2 cytotoxic chemotherapy treatment regimens for metastatic disease.
* prior exposure to 5-Fluorouracil continuous infusion.
* prior exposure docetaxol for metastatic disease
* Any other cancer within 5 years prior to screening with the exception of contralateral breast cancer,adequately treated cervical carcinoma in situ,or adequately treated basal or squamous cell carcinoma of skin
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00717951
Study Brief:
Protocol Section:
NCT00717951