Clinical trial · Interventional
Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Primary endpoint measure not suitable for evaluation
Summary
Brief summary (as posted)
By applying short electric pulses to cells, the cell membranes can become permeabilised (electroporation). This can be used augment the effect of chemotherapy, by providing direct access to the cell cytosol. For the drug bleomycin, the enhancement of effect is several hundred fold, enabling once-only treatment. We wish to offer electrochemotherapy to breast cancer patients suffering from chest wall recurrences that are ulcerated or painful and where other treatments have failed.
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 |
|---|---|---|---|
| Electrochemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- description
- Patients with local-regional recurrence of breast cancer, lesion over 3 cm.
- interventionNames
- Procedure: Electrochemotherapy
Primary outcomes (1)
- measure
- Clinical Measure of Lesion Size.
- timeFrame
- up to one year
- description
- Response was evaluated clinical using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and documented with digital photography. Number of patients with objective response evaluated with clinical measure of lesion size
Secondary outcomes (2)
- measure
- Participants With Objective Response Evaluated With PET/CT
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 * Histological proven cancer of the breast. * Progressive and/or metastatic disease. * No further standard treatment for the patient available or the patient does not wish to receive the offered standard treatment. * If Endocrine therapy: Progression in cutaneous lesions. * If treatment with trastuzumab (Herceptin)can continue this treatment if there is no regression in cutaneous lesions. * At least 2 weeks since last chemotherapy, patients treated with Navelbine (Vinorelbine), Capecitabin (Xeloda) or weekly Paclitaxel (Taxol)can continue this treatment if there is no regression in cutaneous metastases. * Malignant cutaneous or subcutaneous lesion to be treated ≥ 3 cm. * WHO performance ≤ 2. * Life expectancy of at least 3 months. * Platelets ≥ 50 mia/l, pp ≥ 40, APTT in normal area. Medical correction is allowed. * Sexual active men and women must use safe anticonceptive during and up to 6 month after last treatment. * Written informed consent must be obtained according to the local Ethics committee requirements. Exclusion Criteria: * Acute lung infection * Previous bleomycin treatment exceeding 200.000 Units/m2. * Known hypersensitivity to any of the components of the treatment. * Known hypersensitivity to any of the components used in the planned anesthesia. * Pregnant or lactating women. In fertile women this is ensured by measuring HCG in blood. * Treatment with granulocyte colony stimulating factor (G-CSF) or other cytokines.
References
Publications (1)
- RESULTMatthiessen LW, Johannesen HH, Hendel HW, Moss T, Kamby C, Gehl J. Electrochemotherapy for large cutaneous recurrence of breast cancer: a phase II clinical trial. Acta Oncol. 2012 Jul;51(6):713-21. doi: 10.3109/0284186X.2012.685524. Epub 2012 Jun 26. PMID 22731832