Clinical trial · Interventional
Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Ductal Carcinoma In Situ of the Breast
A HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS
- 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 made from peptides and a person's white blood cells may help the body build an effective immune response to kill tumor cells. Injecting the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells. Giving vaccine therapy before surgery may be effective treatment for ductal carcinoma in situ of the breast. PURPOSE: This phase I trial is studying the side effects and best way to give vaccine therapy in treating patients who are undergoing surgery for ductal carcinoma in situ of the breast.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| therapeutic autologous dendritic cells | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR DCIS with microinvasion (\< 1 mm) by core biopsy or excisional biopsy * HER2/neu positive tumor, defined as \> 10% of the tumor population expressing HER2/neu by immunohistochemical staining * No evidence of invasive disease by MRI (performed within the past month) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * Over 18 Sex * Not specified Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * No thrombocytopenia (i.e., platelet count \< 75,000/mm\^3) * No other coagulopathy Hepatic * No hepatitis C positivity * INR \> 1.5 * PTT \> 50 sec Renal * Not specified Cardiovascular * Ejection fraction ≥ 50% by MUGA or echocardiogram * No major cardiac illness Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No HIV positivity * No toxicity \> grade 1 * No other pre-existing medical illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * No prior ipsilateral breast or axillary radiotherapy Surgery * No prior ipsilateral axillary dissection * No prior complete excisional biopsy for DCIS Other * No other prior definitive treatment for DCIS * No concurrent medications that would preclude study participation
References
Publications (0)
Data not yet available