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 @ 2:00 PM
Ignite Modification Date:
2025-12-24 @ 2:00 PM
NCT ID:
NCT00017095
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Locally advanced or inflammatory disease
* T4a-d, any N, M0 OR
* Any T, N2 or N3, M0
* Large operable T2 or T3 tumors
* No bilateral breast cancer
* Frozen tumor sample available
* 1 incisional biopsy OR
* 2 trucut biopsies from a 14G needle
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 70 and under
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* WHO 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.2 mg/dL
* SGOT less than 60 IU/L
Renal:
* Creatinine less than 1.35 mg/dL
Cardiovascular:
* LVEF normal by echocardiography or MUGA
Other:
* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No serious uncontrolled medical condition
* No uncontrolled psychiatric or addictive disorders
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
FEMALE
Maximum Age:
70 Years
Study:
NCT00017095
Study Brief:
Protocol Section:
NCT00017095