Clinical trial · Interventional
Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer
Phase II, Single Arm, Single Institution Clinical Trial of Docetaxel and Doxorubicin in Combination With Local Administration of INGN 201 (Ad5CMV-p53) in Locally Advanced Breast Cancer (LABC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ad5CMV-p53 gene | Biological | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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