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 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT00618657
Eligibility Criteria:
* Patients must be women with a histologically confirmed diagnosis of breast cancer that is more than 1 cm and or lymph node positive
* Physical examination, and scans needed for tumor assessment must be performed within 90 days prior to registration
* Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible
* Serum creatinine within normal limits within 90 days prior to registration
* Bilirubin within normal limits within 90 days prior to registration
* Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =\< 2 x the institutional upper limit of normal within 90 days prior to registration
* Absolute neutrophil count (ANC) of \>= 1,500/microliters within 90 days prior to registration
* Platelet count of \>= 100,000/microliters within 90 days prior to registration
* Patients must have a performance status of 0-2 by Zubrod criteria
* Pregnant or nursing women may not participate; women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; pregnancy test required for women of childbearing potential
* In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines; if day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day
* All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT00618657
Study Brief:
Protocol Section:
NCT00618657