Clinical trial · Interventional
Neoadjuvant/Adjuvant Chemotherapy, Vaccine & Adjuvant Radiation Therapy in p53-Overexpressing Stage III Breast Cancer
1) Adenovirus p53 Infected DC Vaccine For Breast Cancer, 2) Translation of Biotechnology Into the Clinic
- 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: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy before and/or after chemotherapy and radiation therapy may cause a stronger immune response. PURPOSE: This randomized phase I/II trial is studying the side effects of two regimens of vaccine therapy and to see how well they work in treating women who are receiving neoadjuvant or adjuvant chemotherapy and adjuvant radiation therapy for stage III breast cancer that overexpresses p53.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous dendritic cell-adenovirus p53 vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations).
- interventionNames
- Biological: autologous dendritic cell-adenovirus p53 vaccine
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6, 8, 10, and 12 weeks after completion of radiotherapy.
- interventionNames
- Biological: autologous dendritic cell-adenovirus p53 vaccine
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed invasive breast cancer meeting the following criteria: * Clinically locally advanced disease (stage III) with a primary tumor at least 4 cm by mammogram, ultrasound, or palpation AND/OR palpable axillary nodes larger than 1 cm * Planned neoadjuvant chemotherapy * p53-overexpressing tumor by immunohistochemistry * Delayed-type hypersensitivity to at least 1 of 3 standard antigens * Female * ECOG 0-1 * WBC \> 4,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Bilirubin \< 2 times upper limit of normal (ULN) * Hepatitis B surface antigen negative * Hepatitis C antibody negative * Creatinine \< 2 times ULNHIV negative * Fertile patients must use effective contraception during and for at least 6 months after study participation Exclusion Criteria: * No prior or concurrent autoimmune disorder * Not pregnant or nursing/negative pregnancy test * No other concurrent illness that would preclude study participation * No prior chemotherapy * No concurrent participation in another therapeutic clinical trial
References
Publications (0)
Data not yet available