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 @ 3:07 AM
Ignite Modification Date:
2025-12-25 @ 3:07 AM
NCT ID:
NCT01658033
Eligibility Criteria:
Inclusion Criteria:
1. age\>=18years
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<=2 and a life expectancy \>= 12 weeks;
3. histological-proven, HER-2 negative measurable stage IV disease;
4. exposure to anthracyclines, taxanes either in the neoadjuvant/adjuvant or in the metastatic setting and had documented disease progression after the firstline or secondline treatment
5. Patients previously treated with radiotherapy were eligible for the study, provided that measurable disease existed outside the radiation field.
6. At least 3 weeks from the prior chemotherapy or radiotherapy. At least 2 weeks from the prior endocrine therapy.
Exclusion Criteria:
1. Patients with active infection or other serious underlying medical conditions
2. Patients had prior treatment with 5-FU infusion and/or oxaliplatin therapy
3. Inadequate bone marrow, liver, renal, medullary, and cardiac functions
4. Evidence of spinal cord compression or brain metastasis
5. 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
6. Pregnant or lactating women
7. Serious uncontrolled intercurrent infection
8. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
9. Serious non-bleeding wound, peptic ulcer or bone fracture
10. Prior dihypopyrimidine dehydrogenase deficiency
11. Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanlised antibodies
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01658033
Study Brief:
Protocol Section:
NCT01658033