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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT00754767
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of breast cancer
* Metastatic disease
* Scheduled to receive ≥ 1 of the following chemotherapy drugs:
* Paclitaxel
* Docetaxel
* Capecitabine
* Gemcitabine hydrochloride
* Concurrent enrollment in the University of Minnesota study "Population Pharmacokinetics and Pharmacogenetics of Gemcitabine in Adult Patients with Solid Tumors" (Human Subjects Code 0508M72989) required
* Albumin-bound paclitaxel (Abraxane)
* Doxorubicin hydrochloride
PATIENT CHARACTERISTICS:
* Life expectancy ≥ 6 months
* Serum creatinine \< 2.0 mg/dL
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No history of seizures
* No uncontrolled hypertension
* No history of stroke
* No malabsorption syndrome
* No cognitive impairment
* No history of psychiatric disability affecting informed consent or compliance with drug intake
* Able to take oral medication
* Able to complete questionnaire(s) alone or with assistance
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No concurrent warfarin
* No concurrent radiotherapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00754767
Study Brief:
Protocol Section:
NCT00754767