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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT00003032
Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed breast cancer Metastatic disease and/or axillary node or chest wall recurrence following mastectomy diagnosed at least 3 months since prior adjuvant chemotherapy Radiologic scans required No inflammatory carcinoma of the breast without metastases (i.e. T4d M0) No previously untreated inflammatory carcinoma of the breast (T4d) No recurrent breast cancer diagnosed less than 3 months since prior adjuvant chemotherapy No history or evidence of CNS (brain or leptomeningeal) metastases Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 16 to 60 Sex: Female Performance status: ECOG 0-2 Menopausal status: Not specified Life expectancy: Not specified Hematopoietic: Hemoglobin at least 100 g/L Granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST and/or ALT no greater than 3 times upper limit of normal OR AST and/or ALT no greater than 5 times upper limit of normal, if liver metastases Bilirubin no greater than 1.5 times upper limit of normal Renal: Serum creatinine no greater than 2 times upper limit of normal Cardiovascular: No history of congestive heart failure OR At least 1 year since prior myocardial infarction LVEF at least 45% or normal (ECHO or MUGA are acceptable) Other: No prior or concurrent malignancies allowed, except adequately treated squamous or basal cell carcinoma of the skin or in situ carcinoma of the cervix, or cancer treated more than 5 years ago and presumed cured Not HIV positive No clinical evidence of AIDS Not pregnant or nursing Effective contraception required of fertile patients No major medical illness precluding safe administration of planned treatment or required follow-up
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifier therapy Chemotherapy: No prior chemotherapy for metastatic or recurrent breast cancer Induction chemotherapy required Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy: Concurrent radiotherapy allowed for pain control or to solitary bone or soft tissue sites Surgery: Prior oophorectomy allowed See Disease Characteristics
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT00003032
Study Brief:
Protocol Section:
NCT00003032