Clinical trial · Observational
Prospective Multicenter Registry of Patients With Skin Metastases From Breast Cancer Treated With Electrochemotherapy
NCT06709937CI-TRIAL-00083139GISELcompletedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Electrochemotherapy (ECT) has been proposed as a new therapeutic option for palliating cutaneous metastases from breast carcinoma.
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 Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prospective multicenter registry of patients with cutaneous metastases from breast carcinoma treated with electrochemotherapy. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with metastatic breast carcinoma
- description
- In patients with metastatic breast carcinoma, the skin is affected in 5-30% of cases. Although constituting a relatively rare event in absolute terms, the onset of cutaneous metastases generally represents an unfavorable prognostic factor (due to synchronous progression of disease in other sites), as well as a condition of difficult therapeutic management. Even in the most favorable cases, cutaneous metastases often lead to a deterioration in the quality of life of patients, linked to their psychological impact and associated symptoms. It is crucial that patients receive timely and effective treatment. In these cases, various therapeutic options are discussed by a multidisciplinary team, and the patient is typically evaluated for systemic treatment (chemotherapy, endocrine therapy, targeted therapy).
- interventionNames
- Other: Prospective multicenter registry of patients with cutaneous metastases from breast carcinoma treated with electrochemotherapy.
Primary outcomes (1)
- measure
- The rate of local response in the entire study population and in the subgroups
- timeFrame
- 1-3-6 months
- description
- Confirmation with a large case series of the results obtained in the multicenter study by the GISEL group
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with cutaneous metastases from breast carcinoma not surgically resectable; * No indications for radiotherapy treatment; * Patients not eligible or not fully responsive to systemic oncologic treatments; * Maximum depth of the lesion from the skin surface: 3 cm; * Patient's life expectancy exceeding 4 months; * Normal hematologic, hepatic, and renal function; * Performance status ≤2 according to the ECOG scale. Exclusion Criteria: * History of allergic reactions to bleomycin or cisplatin; * Exceeding the maximum cumulative dose of bleomycin (250,000 IU/m2); * Peripheral neuropathy (in case of cisplatin use); * Severe hepatic or renal insufficiency; * History of epilepsy; * Presence of a pacemaker; * Severe cardiac arrhythmias (In patients with a history of cardiac arrhythmia, a cardiological evaluation will be performed, and treatment will be applied in the presence of an anesthesiologist. The presence of any type of pacemaker precludes treatment on the thoracic wall); * Pregnancy or breastfeeding; * Unavailability for follow-up visits; * Altered respiratory function or presence of pulmonary fibrosis.
References
Publications (0)
Data not yet available
No reference posted for this study.