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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT00044993
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Stage IIIA, IIIB (excluding inflammatory breast carcinoma), or IIIC OR
* Localized stage IV
* Measurable disease
* No metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Male or female
Menopausal status
* Not specified
Performance status
* Karnofsky 70-100%
Life expectancy
* Not specified
Hematopoietic
* Adequate bone marrow function
Hepatic
* Adequate liver function
* Hepatitis B surface antigen negative
* Hepatitis C antibody negative
Renal
* Adequate kidney function
Cardiovascular
* Normal cardiac function by MUGA and/or echocardiogram
Other
* No psychological, familial, sociological, or geographical conditions that would preclude study
* Not pregnant or nursing
* Fertile patients must use effective barrier method of contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior gene therapy using adenoviral vectors or p53 gene product
Chemotherapy
* No prior chemotherapy for breast cancer
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00044993
Study Brief:
Protocol Section:
NCT00044993