This study evaluated Ad5CMV-p53 gene therapy given together with docetaxel and doxorubicin chemotherapy before surgery (neoadjuvant setting) in patients with stage IIIA, IIIB, IIIC or localised stage IV breast cancer. It was carried out as a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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