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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT00593827
Eligibility Criteria:
Inclusion Criteria:
* Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) ≥ 50
* Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer
* Prior chemotherapy is permitted with no limit on the number of prior regimens
* Two weeks or more have elapsed since last chemotherapy or radiation treatment
* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
* Is female, ≥ 18 yrs of age
* Protocol defined appropriate laboratory values
* Negative pregnancy test within 7 calendar days prior to registration
* Has signed a patient informed consent
Exclusion Criteria:
* Had prior treatment with ixabepilone or other epothilones
* Has HER2+ disease
* Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events \[NCI CTCAE\] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)
* Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy
* Is receiving concurrent investigational therapy or has received such therapy within the past 30 days
* Has peripheral neuropathy \> Grade 1
* Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible
* Is pregnant or breast feeding
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00593827
Study Brief:
Protocol Section:
NCT00593827