Breast Cancer FemaleGISELNCT06709937
Prospective Multicenter Registry of Patients With Skin Metastases From Breast Cancer Treated With Electrochemotherapy
An observational study of Breast Cancer Female, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Electrochemotherapy (ECT) has been proposed as a new therapeutic option for palliating cutaneous metastases from breast carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Prospective multicenter registry of patients with cutaneous metastases from breast carcinoma treated with electrochemotherapy.
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jul 2020to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, 00168
About this study
Electrochemotherapy (ECT) has been proposed as a new therapeutic option for palliating cutaneous metastases from breast carcinoma.
Read the detailed description
Electrochemotherapy
Recently, electrochemotherapy (ECT) has been proposed as a new therapeutic option for palliating cutaneous metastases from breast carcinoma. Over the last decade, ECT has represented an innovative and effective local/regional therapy in the field of dermato-oncology. In brief, it consists of combining chemotherapy with the local application (at the tumor site) of electric pulses. Through the application of short and intense electric pulses, a physical phenomenon (reversible electroporation) occurs, consisting of the temporary opening of pores through the cell membrane, increasing its permeability. This mechanism allows for the diffusion of poorly permeable drugs into the cytoplasm. Once the transmembrane pores close, after a few milliseconds, the final effect is the concentration of the chemotherapeutic drug inside the cell and an increase in its cytotoxic effect. The enhancement of cytotoxic action ranges from 80 (in the case of cisplatin) to 8000 times (in the case of bleomycin).
Clinical experience with electrochemotherapy
The initial clinical experiences in treating patients with cutaneous metastases using ECT demonstrated very promising results in tumors of various histotypes. After the standardization of the method, studies published over the last decade provide extensive evidence that ECT has high antitumor activity. The most extensive experience has been primarily gathered in patients with superficial metastases from melanoma and breast carcinoma and has also been the subject of a meta-analysis comparing different "skin-directed" therapies.
In current clinical practice, ECT is employed as a complementary or alternative treatment in the management of tumors and cutaneous metastases that are not surgically resectable or not amenable to treatment with radiotherapy or systemic oncologic therapies. Thanks to its relative ease of application and low toxicity profile, ECT represents an effective tool for palliating symptomatic superficial metastases (bleeding, ulcerated, painful), ensuring preservation of the patient's quality of life regarding aspects related to the presence of the disease at the cutaneous level.
The main advantages of treatment with ECT are represented by the following factors:
- possibility of administration on a day-surgery/day-hospital basis
- preservation of healthy tissues
- use of relatively low-toxicity antitumor drugs
- possibility of repeated treatment
- favorable toxicity profile (side effects are mostly cutaneous)
- good patient compliance
The use of the method has progressively increased, especially in Europe, following the publication of European Standard Operative Procedures of Electrochemotherapy (ESOPE) in 2006. These guidelines served as the basis for conducting a multicenter European study (ESOPE Study) that demonstrated the feasibility of the indicated operative modalities and the safety of the procedure.
Clinical experience with electrochemotherapy in breast carcinoma
Clinical experiences in subsequent years have been summarized in two recent meta-analyses, mainly based on studies in patients with melanoma and breast carcinoma, where ECT demonstrated a complete response rate of 59% and 57.5%, respectively. A phase 2 study conducted at the Veneto Oncology Institute in Padua on 34 patients with recurrent cutaneous lesions on the thoracic wall reported an overall response rate of 87%, with 40% of patients achieving a complete and lasting response on the treated lesions. Comparable results have been obtained in other smaller experiences reported in the literature.
More recently, a multicenter retrospective study was published by the Italian Senological Group for Electrochemotherapy (GISEL) based on 125 patients with cutaneous metastases from breast carcinoma. According to the data from this study, the response rate to ECT was 90%, with 58% of patients reporting a complete response. In this study, tumor size (<3cm), presence of hormonal receptors, low proliferative index (Ki-67), absence of tumor ulceration, and absence of visceral metastases were predictive factors for a complete response to treatment. Based on this data and subdividing patients into intrinsic subtypes indicated by the St. Gallen classification, patients with "luminal A-like" type tumors reported a significantly higher complete response rate than all others (73.9% vs 54.7%, P=0.02).
If these preliminary observations were confirmed by a prospective study on a larger case series, it could improve the criteria for selecting patients with breast carcinoma eligible for ECT treatment.
- Conditions
- Breast Cancer Female
- Being tested
- Prospective multicenter registry of patients with cutaneous metastases from breast carcinoma treated with electrochemotherapy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective multicenter registry of patients with cutaneous metastases from breast carcinoma treated with electrochemotherapy.Other
electrochemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Prospective multicenter registry of patients with cutaneous metastases from breast carcinoma treated with electrochemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start6 Jul 2020
- Primary completion31 Jan 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corrado Giacomo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Giacomo Corrado, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709937
- Sponsor's protocol ID
- 2509
- Acronym
- GISEL
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Registry of Patients With Skin Metastases From Breast Cancer Treated With Electrochemotherapy
- ClinicalTrials.gov ID
- NCT06709937
- Acronym / sponsor ID
- GISEL / 2509
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electrochemotherapy (ECT) has been proposed as a new therapeutic option for palliating cutaneous metastases from breast carcinoma.
Detailed description
Electrochemotherapy
Recently, electrochemotherapy (ECT) has been proposed as a new therapeutic option for palliating cutaneous metastases from breast carcinoma. Over the last decade, ECT has represented an innovative and effective local/regional therapy in the field of dermato-oncology. In brief, it consists of combining chemotherapy with the local application (at the tumor site) of electric pulses. Through the application of short and intense electric pulses, a physical phenomenon (reversible electroporation) occurs, consisting of the temporary opening of pores through the cell membrane, increasing its permeability. This mechanism allows for the diffusion of poorly permeable drugs into the cytoplasm. Once the transmembrane pores close, after a few milliseconds, the final effect is the concentration of the chemotherapeutic drug inside the cell and an increase in its cytotoxic effect. The enhancement of cytotoxic action ranges from 80 (in the case of cisplatin) to 8000 times (in the case of bleomycin).
Clinical experience with electrochemotherapy
The initial clinical experiences in treating patients with cutaneous metastases using ECT demonstrated very promising results in tumors of various histotypes. After the standardization of the method, studies published over the last decade provide extensive evidence that ECT has high antitumor activity. The most extensive experience has been primarily gathered in patients with superficial metastases from melanoma and breast carcinoma and has also been the subject of a meta-analysis comparing different "skin-directed" therapies.
In current clinical practice, ECT is employed as a complementary or alternative treatment in the management of tumors and cutaneous metastases that are not surgically resectable or not amenable to treatment with radiotherapy or systemic oncologic therapies. Thanks to its relative ease of application and low toxicity profile, ECT represents an effective tool for palliating symptomatic superficial metastases (bleeding, ulcerated, painful), ensuring preservation of the patient's quality of life regarding aspects related to the presence of the disease at the cutaneous level.
The main advantages of treatment with ECT are represented by the following factors:
- possibility of administration on a day-surgery/day-hospital basis
- preservation of healthy tissues
- use of relatively low-toxicity antitumor drugs
- possibility of repeated treatment
- favorable toxicity profile (side effects are mostly cutaneous)
- good patient compliance
The use of the method has progressively increased, especially in Europe, following the publication of European Standard Operative Procedures of Electrochemotherapy (ESOPE) in 2006. These guidelines served as the basis for conducting a multicenter European study (ESOPE Study) that demonstrated the feasibility of the indicated operative modalities and the safety of the procedure.
Clinical experience with electrochemotherapy in breast carcinoma
Clinical experiences in subsequent years have been summarized in two recent meta-analyses, mainly based on studies in patients with melanoma and breast carcinoma, where ECT demonstrated a complete response rate of 59% and 57.5%, respectively. A phase 2 study conducted at the Veneto Oncology Institute in Padua on 34 patients with recurrent cutaneous lesions on the thoracic wall reported an overall response rate of 87%, with 40% of patients achieving a complete and lasting response on the treated lesions. Comparable results have been obtained in other smaller experiences reported in the literature.
More recently, a multicenter retrospective study was published by the Italian Senological Group for Electrochemotherapy (GISEL) based on 125 patients with cutaneous metastases from breast carcinoma. According to the data from this study, the response rate to ECT was 90%, with 58% of patients reporting a complete response. In this study, tumor size (<3cm), presence of hormonal receptors, low proliferative index (Ki-67), absence of tumor ulceration, and absence of visceral metastases were predictive factors for a complete response to treatment. Based on this data and subdividing patients into intrinsic subtypes indicated by the St. Gallen classification, patients with "luminal A-like" type tumors reported a significantly higher complete response rate than all others (73.9% vs 54.7%, P=0.02).
If these preliminary observations were confirmed by a prospective study on a larger case series, it could improve the criteria for selecting patients with breast carcinoma eligible for ECT treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with metastatic breast carcinoma | – | Other: Prospective multicenter registry of patients with cutaneous metastases from breast carcinoma treated with electrochemotherapy.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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective multicenter registry of patients with cutaneous metastases from breast carcinoma treated with electrochemotherapy.electrochemotherapy. | Other | Patients with metastatic breast carcinoma |
Primary outcome
The rate of local response in the entire study population and in the subgroups
Time frame: 1-3-6 months
Confirmation with a large case series of the results obtained in the multicenter study by the GISEL group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giacomo Corrado principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of local response in the entire study population and in the subgroups (time frame: 1-3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.