Prospective Multicenter Registry of Patients With Skin Metastases From Breast Cancer Treated With Electrochemotherapy

NCT06709937 | Completed

• 1 other identifier: 2509
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Electrochemotherapy (ECT) has been proposed as a new therapeutic option for palliating cutaneous metastases from breast carcinoma.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• The rate of local response in the entire study population and in the subgroups

  Confirmation with a large case series of the results obtained in the multicenter study by the GISEL group

  1-3-6 months

Study Arms (1)

Patients with metastatic breast carcinoma

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).

Other: Prospective multicenter registry of patients with cutaneous metastases from breast carcinoma treated with electrochemotherapy.

Interventions

Prospective multicenter registry of patients with cutaneous metastases from breast carcinoma treated with electrochemotherapy. OTHER

electrochemotherapy.

Patients with metastatic breast carcinoma

Eligibility Criteria

• Age: 18 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To test the hypothesis of a significant difference between two proportions (73.9% vs 54.7%) using a one-tailed likelihood ratio test, with a statistical power of 90% and a target significance level of 5%, 351 patients are required (64 in the "luminal A-like" group and 287 in the non-"luminal A-like" group).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Interventions

Electrochemotherapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Electroporation Therapies; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Giacomo Corrado

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 29, 2024
• Study Start: July 6, 2020
• Primary Completion: January 31, 2023
• Study Completion: April 30, 2023
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

IT (1)