Clinical trial NCT06683404: GISEL:Registry of Breast Cancer Patients Treated With ECT
Official title: GISEL (Italian Senologic Group for Electrochemotherapy): Prospective Multicenter Registry of Breast Cancer Patients With Skin Metastases Treated by Electrochemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Breast Cancer Metastatic
Breast Cancer Recurrent
Keywords: bleomycin
breast cancer
breast cancer cutaneous and subcutaneous metastasis
electrochemotherapy
breast cancer treatment
electroporation
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Local response
timeFrame: 4 and 8 weeks
measure: Treatment toxicity
timeFrame: 1 and 2 weeks and 1, 2, 3, 6 and 12 months
Secondary outcomes:
measure: Local progression-free survival (LPFS)
timeFrame: 1, 2 , 3 , 6 and 12 months (through study completion, an average of 1 year).
measure: Quality of life and pain relief
timeFrame: 1 and 2 weeks, and at 1, 2, 3, 6 and 12 months
measure: Quality of life and pain relief
timeFrame: 1 and 2 weeks, and at 1, 2, 3, 6 and 12 months
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Veneto Institute of Oncology IRCCS
Study officials:
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