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 @ 3:21 PM
Ignite Modification Date:
2025-12-24 @ 3:21 PM
NCT ID:
NCT01655992
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed breast cancer
* Pretreated metastatic breast cancer not more than 2 lines chemotherapy
* Have not been previously treated with capecitabine,oral fluracil
* ECOG performance status of ≤ 1
* Be female and ≥ 18 and ≤ 75 years of age
* Have at least one target lesion according to the RECIST criteria 1.1
Exclusion Criteria:
* Pregnant or lactating women
* ECOG ≥ 2
* Have been treated with capecitabine
* Evidence of CNS metastasis
* History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
* Abnormal laboratory values: hemoglobin \< 10.0 g/dl, absolute neutrophil count \< 1.5×10\^9/L, platelet count \< 100×10\^9/L, serum creatinine \> upper limit of normal (ULN), serum bilirubin \> ULN, ALT and AST \> 5×ULN, AKP \> 5×ULN
* Serious uncontrolled intercurrent infection
* Life expectancy of less than 3 months
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01655992
Study Brief:
Protocol Section:
NCT01655992