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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT00645333
Eligibility Criteria:
Inclusion Criteria:
* Men or women with metastatic (Stage IV) breast cancer, or with locally advanced breast cancer (Stages IIIA \> 10 cm, or Stages IIIB and IIIC) that did not respond to first-line anthracycline-based chemotherapy, for whom docetaxel is a recommended therapy
* Presence of measurable or evaluable disease
* Adequate organ function
* Ability to swallow intact study drug capsules
* Zubrod Performance Status of 0-1 with at least a 3 month life expectancy
* Appropriate time must have elapsed since prior anti-neoplastic therapy with resolution of acute toxicity
Exclusion Criteria:
* Concurrent treatment with hormonal therapy intended to treat cancer
* Radiotherapy within 7 days prior to first dose
* Symptomatic central nervous system, and/or epidural metastases or symptomatic carcinomatous meningitis or with radiation treatment completed within the past 8 weeks
* Serious comorbid illness which will limit the ability of the patient to safely receive anticancer treatment
* Patients who are pregnant or nursing
* Confounding factors present to provide misinterpretation of data (i.e., concurrent malignancy)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00645333
Study Brief:
Protocol Section:
NCT00645333