Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breas… (NCT00044993) | Clinical Trial Compass
CompletedPhase 2
Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer
United StatesStarted 2002-02
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Inserting the p53 gene into the tumor may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. Combining chemotherapy with gene therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with gene therapy in treating patients who have stage III or stage IV breast cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.