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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT00225056
Eligibility Criteria:
Inclusion Criteria:
* must have metastatic breast cancer
* must have cytologically or pathologically confirmed invasive ductal or lobular carcinoma
* must have measurable or evaluable disease
* ECOG of 0-1
* patients may have received 0, 1. or 2 prior treatments for metastatic breast cancer
* must have adequate organ function
* must be at least 19 years of age
* peripheral neuropathy less than or equal to grade 1
* must have voluntarily signed informed consent
* patients with brain metastases are eligible provided that other measurable disease exists and brain lesions are controlled
Exclusion Criteria:
* patients with other malignancies, except non melanoma of the skin, who have had any evidence of cancer within the last 5 years
* patients with psychiatric illness or other concurrent severe co-morbid medical condition that would preclude study completion
* known uncontrolled existing coagulopathy
* patients with a history of severe hypersensitivity reaction to docetaxel, medications formulated with polysorbate 80 or 5-fluorouracil
* use of other investigational agents in the last 28 days
* pregnant or lactating women
* patients who are known HIV positive
* patients with life expectancy of less than 3 months
* sexually active patients unwilling to practice reliable contraception during the study
Sex:
FEMALE
Minimum Age:
19 Years
Maximum Age:
85 Years
Study:
NCT00225056
Study Brief:
Protocol Section:
NCT00225056