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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT00003035
Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven locally advanced breast cancer Unresected T3 or T4 lesion, OR Unresected T2 lesion if patient considered appropriate candidate for neoadjuvant chemotherapy to enhance breast conservation Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal Renal: Creatinine no greater than 1.5 times normal Cardiovascular: LVEF at least 50% (baseline MUGA) No history of uncontrolled congestive heart failure At least 6 months since prior myocardial infarction No unstable angina No uncontrolled hypertension Neurologic: No peripheral neuropathy Other: Not pregnant or nursing No psychosis
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic therapy Endocrine therapy: No prior hormonal therapy for breast cancer Prior estrogen replacement therapy allowed No concurrent steroid therapy Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No concurrent treatment for serious infection (bacterial, viral, or fungal)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00003035
Study Brief:
Protocol Section:
NCT00003035