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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT00454532
Eligibility Criteria:
Key Inclusion Criteria:
* Women 18 years or older
* Histologically confirmed breast cancer
* Clinical evidence of metastatic (stage IV) metastasis (other than bone metastasis)
* Availability of estrogen and progesterone receptor status
* At least one measurable disease site defined by RECIST criteria, 30 days prior to study therapy
* For the phase 1, no more that 3 prior cytotoxic regimens for metastatic breast cancer. For the phase 2, no more than 2 prior cytotoxic regimens for metastatic breast cancer
* Life expectancy ≥ 12 weeks
* Eastern Cooperative Oncology Group performance status ≤2
* Women of child bearing potential must agree to 2 forms of contraception during the course of the trial.
Key Exclusion Criteria:
* Inability to understand/unwillingness to sign a written informed consent
* Any significant side effects related to prior chemo, radiation, biology or hormonal therapy that did not resolve in the judgment of the investigator
* Currently using an investigational agent
* Clinically significant gastrointestinal abnormalities
* Currently using coumadin at therapeutic doses or within 2 weeks of taking study medication
* Concurrent palliative radiation or anti-cancer treatment
* Women who report pregnancy, are breast-feeding or have a positive pregnancy test
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00454532
Study Brief:
Protocol Section:
NCT00454532