GISEL:Registry of Breast Cancer Patients Treated With ECT

Completed

• Conditions: Breast Cancer; Breast Cancer Recurrent; Breast Cancer Metastatic
• Interventions: Device: Electrochemotherapy (ECT); Drug: Bleomycin

• Registration Number: NCT06683404
• Lead Sponsor: Istituto Oncologico Veneto IRCCS

Brief Summary

Electrochemotherapy (ECT) is a safe skin-directed treatment for cancer which combines drug treatment with short electric pulses to the tumor. The procedure lasts 20-40 minutes and is generally performed under sedation. It generally allows for a fast recovery with low discomfort.

The aims of this study are to find out how well ECT works in patients with breast cancer that has spread to the skin (cutaneous metastases), and to find out which patients have the best response to the treatment.

Detailed Description

In patients with metastatic breast cancer, the skin is affected in 5-30% of cases. Although a relatively uncommon event in absolute terms, the occurrence of skin metastases generally represents an unfavourable prognostic factor (due to simultaneous or imminent disease progression in other sites), as well as a condition of difficult therapeutic management. Even in the most favourable cases, in which the disease is still confined to the locoregional level, cutaneous metastases often entail a worsening of the patients' quality of life, linked to their psychological impact and to the related symptoms (pain, ulceration, bleeding, infection). It is therefore of paramount importance that patients receive timely and effective treatment. Surgical excision represents the simplest and quickest approach to ensure local control of the disease; when the surgical option is not radically feasible, locoregional treatments may be considered. Electrochemotherapy (ECT) has been proposed as a new treatment option for the palliation of skin metastases from breast cancer. Briefly, it consists of the combination of chemotherapy with the local application (at the tumour) of electrical impulses. Through the application of short, intense electrical impulses, a physical phenomenon (reversible electroporation) is produced, which consists of the temporary opening of pores through the cell membrane that increase its permeability. This mechanism allows the diffusion into the cytoplasm of drugs that are in themselves not very permeable. The final effect is an increase in the cytotoxic effect of the drug. The enhancement of cytotoxic action ranges from 80 (in the case of cisplatin) up to 8000 times (in the case of bleomycin). In current clinical practice, ECT is used, as a complementary or alternative treatment, in the management of patients with skin tumours and superficial metastases that cannot be surgically removed or are not amenable to treatment by radiotherapy or systemic oncological therapies. Due to its relative ease of application and favourable toxicity profile, ECT is currently an effective tool for the palliation of symptomatic (bleeding, ulcerated, painful) superficial metastases, thus contributing to the preservation of the patient's quality of life.Recent retrospective studies based on patients with skin metastases from breast cancer treated with ECT found local response rates to treatment of 90%, with 58% of patients reporting complete regression. If these preliminary observations were confirmed in a prospective, larger case series study, the criteria for selecting breast cancer patients eligible for treatment with ECT could be improved.

Study Timeline

• Study Start: 2016-04-22
• Primary Completion: 2021-10-21
• Study Completion: 2022-12-10
• Status Verified: 2024-01
• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-11-08
• Last Update Submitted: 2024-11-08
• Study First Posted: 2024-11-11
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

1. Cutaneous metastases from breast cancer
2. No indication to surgical resection
3. No indication to treatment with radiotherapy
4. Ineligibility or unresponsiveness to systemic cancer treatment
5. Maximum tumor depth (from the skin layer): 3 cm
6. Patient's life expectancy greater than 4 months
7. Normal hematology, hepatic and renal function
8. Performance status (ECOG) ≤2
9. At least 18 years old

Exclusion Criteria

1. History of allergic reaction to bleomycin
2. Exceeding the maximum cumulative dose of bleomycin (250,000 IU / m2)
3. Severe impairment of lung, liver or kidney function
4. History of epilepsy
5. Presence of a cardiac pacemaker
6. Serious cardiac arrhythmias
7. Pregnancy or lactation
8. Unwillingness to attend the clinic for follow-up visits
9. Impaired respiratory function or presence of pulmonary fibrosis -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast Cancer patients with cutaneous and/or subcutaneous histologically confirmed metastases	Electrochemotherapy (ECT)	Breast Cancer patients with cutaneous and/or subcutaneous histologically confirmed metastases, regardless of the presence of other metastases, which underwent Electrochemotherapy for the local treatment of their cutaneous and/or subcutaneous metastases.
Breast Cancer patients with cutaneous and/or subcutaneous histologically confirmed metastases	Bleomycin	Breast Cancer patients with cutaneous and/or subcutaneous histologically confirmed metastases, regardless of the presence of other metastases, which underwent Electrochemotherapy for the local treatment of their cutaneous and/or subcutaneous metastases.

Primary Outcome Measures

Name	Time	Method
Local response	4 and 8 weeks	Local response to the treatment, assessed using clinical examination and graded according to the Response Evaluation Criteria In Solid Tumors (RECIST).
Treatment toxicity	1 and 2 weeks and 1, 2, 3, 6 and 12 months	Treatment toxicity, assessed using clinical examination and graded according to the Common Terminology Criteria for Adverse Events (CTCAE v4.0).

Secondary Outcome Measures

Name	Time	Method
Local progression-free survival (LPFS)	1, 2 , 3 , 6 and 12 months (through study completion, an average of 1 year).	Local progression-free survival (LPFS), assessed using physical examination
Quality of life and pain relief	1 and 2 weeks, and at 1, 2, 3, 6 and 12 months	measured using scale (VNS) Verbal Numerical Rating Score (where 0 is no pain and 10 is the worst pain imaginable)

Trial Locations

Locations (1)

Veneto Institute of Oncology IRCCS; 🇮🇹 Padova, Italy