Breast CancerGISELNCT06683404
GISEL:Registry of Breast Cancer Patients Treated With ECT
An observational study of Breast Cancer and Breast Cancer Metastatic, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Cancer Metastatic, Breast Cancer Recurrent
- What is being tested?
- Electrochemotherapy (ECT) and Bleomycin
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 205 participants
- Where
- 1 siteItaly
- Study dates
- 22 Apr 2016to 10 Dec 2022
- How long will I take part?
- 12 Months
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Cutaneous metastases from breast cancer
- No indication to surgical resection
- No indication to treatment with radiotherapy
- Ineligibility or unresponsiveness to systemic cancer treatment
- Maximum tumor depth (from the skin layer): 3 cm
- Patient's life expectancy greater than 4 months
Show all 9Show fewer
- Normal hematology, hepatic and renal function
- Performance status (ECOG) ≤2
- At least 18 years old
Who cannot join
- History of allergic reaction to bleomycin
- Exceeding the maximum cumulative dose of bleomycin (250,000 IU / m2)
- Severe impairment of lung, liver or kidney function
- History of epilepsy
- Presence of a cardiac pacemaker
- Serious cardiac arrhythmias
Show all 9Show fewer
- Pregnancy or lactation
- Unwillingness to attend the clinic for follow-up visits
- Impaired respiratory function or presence of pulmonary fibrosis -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GISEL (Italian Senologic Group for Electrochemotherapy): Prospective Multicenter Registry of Breast Cancer Patients With Skin Metastases Treated by Electrochemotherapy
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.
Read the 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.
- Being tested
- Electrochemotherapy (ECT), Bleomycin
- Keywords
- bleomycin, breast cancer, breast cancer cutaneous and subcutaneous metastasis, electrochemotherapy, breast cancer treatment, electroporation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrochemotherapy (ECT)Device
Electrochemotherapy (ECT) is characterized by the association between the administration of a chemotherapic agent (Bleomycin) with the temporary raise of permeability of the cellular membrane induced by the local administration of electrical impulses (electroporation). ECT represents an effective therapy for loco-regional control of this disease.
BleomycinDrug
Electrochemotherapy (ECT) is characterized by the association between the administration of a chemotherapic agent (Bleomycin) with the temporary raise of permeability of the cellular membrane
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer patients with cutaneous and/or subcutaneous histologically confirmed metastases | 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. Receives: Device: Electrochemotherapy (ECT); Drug: Bleomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local response
Local response to the treatment, assessed using clinical examination and graded according to the Response Evaluation Criteria In Solid Tumors (RECIST).
Measured: 4 and 8 weeks
Treatment toxicity
Treatment toxicity, assessed using clinical examination and graded according to the Common Terminology Criteria for Adverse Events (CTCAE v4.0).
Measured: 1 and 2 weeks and 1, 2, 3, 6 and 12 months
Secondary outcomes (3)
Local progression-free survival (LPFS)
Local progression-free survival (LPFS), assessed using physical examination
Measured: 1, 2 , 3 , 6 and 12 months (through study completion, an average of 1 year).
Quality of life and pain relief
measured using questionnaire (EQ-5D) EuroQol-5D (The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems) .
Measured: 1 and 2 weeks, and at 1, 2, 3, 6 and 12 months
Quality of life and pain relief
measured using scale (VNS) Verbal Numerical Rating Score (where 0 is no pain and 10 is the worst pain imaginable)
Measured: 1 and 2 weeks, and at 1, 2, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start22 Apr 2016
- Primary completion21 Oct 2021
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683404
- Sponsor's protocol ID
- Cod. Int. CE IOV 2017/11
- Acronym
- GISEL
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analysed during the current study are/will be available upon request from Prof.Marco Rastrelli (marco.rastrelli@unipd.it)
Publications
Wong CY, Helm MA, Kalb RE, Helm TN, Zeitouni NC. The presentation, pathology, and current management strategies of cutaneous metastasis. N Am J Med Sci. 2013 Sep;5(9):499-504. doi: 10.4103/1947-2714.118918.
PubMed 24251266Zagar TM, Higgins KA, Miles EF, Vujaskovic Z, Dewhirst MW, Clough RW, Prosnitz LR, Jones EL. Durable palliation of breast cancer chest wall recurrence with radiation therapy, hyperthermia, and chemotherapy. Radiother Oncol. 2010 Dec;97(3):535-40. doi: 10.1016/j.radonc.2010.10.020. Epub 2010 Nov 11.
PubMed 21074876Oldenborg S, Van Os RM, Van rij CM, Crezee J, Van de Kamer JB, Rutgers EJ, Geijsen ED, Zum vorde sive vording PJ, Koning CC, Van tienhoven G. Elective re-irradiation and hyperthermia following resection of persistent locoregional recurrent breast cancer: A retrospective study. Int J Hyperthermia. 2010;26(2):136-44. doi: 10.3109/02656730903341340.
PubMed 20146568Matthiessen LW, Johannesen HH, Hendel HW, Moss T, Kamby C, Gehl J. Electrochemotherapy for large cutaneous recurrence of breast cancer: a phase II clinical trial. Acta Oncol. 2012 Jul;51(6):713-21. doi: 10.3109/0284186X.2012.685524. Epub 2012 Jun 26.
PubMed 22731832Belehradek M, Domenge C, Luboinski B, Orlowski S, Belehradek J Jr, Mir LM. Electrochemotherapy, a new antitumor treatment. First clinical phase I-II trial. Cancer. 1993 Dec 15;72(12):3694-700. doi: 10.1002/1097-0142(19931215)72:123.0.co;2-2.
PubMed 7504576Heller R, Jaroszeski MJ, Reintgen DS, Puleo CA, DeConti RC, Gilbert RA, Glass LF. Treatment of cutaneous and subcutaneous tumors with electrochemotherapy using intralesional bleomycin. Cancer. 1998 Jul 1;83(1):148-57. doi: 10.1002/(sici)1097-0142(19980701)83:13.0.co;2-w.
PubMed 9655305Rodriguez-Cuevas S, Barroso-Bravo S, Almanza-Estrada J, Cristobal-Martinez L, Gonzalez-Rodriguez E. Electrochemotherapy in primary and metastatic skin tumors: phase II trial using intralesional bleomycin. Arch Med Res. 2001 Jul-Aug;32(4):273-6. doi: 10.1016/s0188-4409(01)00278-8.
PubMed 11440782Mir, LM, Gehl J, Sersa G, et al. Standard operatimg procedures of the electrochemotherapy: instructions for the use of bleomycin or cisplatin administered either systemically or locally and electric pulses delivered by the CliniporatorTM by means of invasive or non-invasive electrodes. Eur J Cancer 2006; 4(suppl 11):14-25
Marty M, Sersa G, Garbay JR, et al. Electrochemotherapy - an easy, highly effective and safe treatment of cutaneous and subcutaneous metastases. Results of ESOPE (European Standard Operating Procedures of Electrochemotherapy) study. European Journal of Cancer Supplements 4 (2006) 3-13.
Spratt DE, Gordon Spratt EA, Wu S, DeRosa A, Lee NY, Lacouture ME, Barker CA. Efficacy of skin-directed therapy for cutaneous metastases from advanced cancer: a meta-analysis. J Clin Oncol. 2014 Oct 1;32(28):3144-55. doi: 10.1200/JCO.2014.55.4634. Epub 2014 Aug 25.
PubMed 25154827Cabula C, Campana LG, Grilz G, Galuppo S, Bussone R, De Meo L, Bonadies A, Curatolo P, De Laurentiis M, Renne M, Valpione S, Fabrizio T, Solari N, Guida M, Santoriello A, D'Aiuto M, Agresti R. Electrochemotherapy in the Treatment of Cutaneous Metastases from Breast Cancer: A Multicenter Cohort Analysis. Ann Surg Oncol. 2015 Dec;22 Suppl 3:S442-50. doi: 10.1245/s10434-015-4779-6. Epub 2015 Aug 5.
PubMed 26242370Campana LG, Valpione S, Falci C, Mocellin S, Basso M, Corti L, Balestrieri N, Marchet A, Rossi CR. The activity and safety of electrochemotherapy in persistent chest wall recurrence from breast cancer after mastectomy: a phase-II study. Breast Cancer Res Treat. 2012 Aug;134(3):1169-78. doi: 10.1007/s10549-012-2095-4. Epub 2012 Jul 24.
PubMed 22821399Benevento R, Santoriello A, Perna G, Canonico S. Electrochemotherapy of cutaneous metastastes from breast cancer in elderly patients: a preliminary report. BMC Surg. 2012;12 Suppl 1(Suppl 1):S6. doi: 10.1186/1471-2482-12-S1-S6. Epub 2012 Nov 15.
PubMed 23173816Solari N, Spagnolo F, Ponte E, Quaglia A, Lillini R, Battista M, Queirolo P, Cafiero F. Electrochemotherapy for the management of cutaneous and subcutaneous metastasis: a series of 39 patients treated with palliative intent. J Surg Oncol. 2014 Mar;109(3):270-4. doi: 10.1002/jso.23481. Epub 2013 Oct 28.
PubMed 24165992Mali B, Jarm T, Snoj M, Sersa G, Miklavcic D. Antitumor effectiveness of electrochemotherapy: a systematic review and meta-analysis. Eur J Surg Oncol. 2013 Jan;39(1):4-16. doi: 10.1016/j.ejso.2012.08.016. Epub 2012 Sep 11.
PubMed 22980492
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GISEL (Italian Senologic Group for Electrochemotherapy): Prospective Multicenter Registry of Breast Cancer Patients With Skin Metastases Treated by Electrochemotherapy
- ClinicalTrials.gov ID
- NCT06683404
- Acronym / sponsor ID
- GISEL / Cod. Int. CE IOV 2017/11
- Keywords
- bleomycin, breast cancer, breast cancer cutaneous and subcutaneous metastasis, electrochemotherapy, breast cancer treatment, electroporation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Study start
- 22 Apr 2016
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 12 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) 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer patients with cutaneous and/or subcutaneous histologically confirmed metastases | – | Device: Electrochemotherapy (ECT), Drug: BleomycinBreast 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Cutaneous metastases from breast cancer
- No indication to surgical resection
- No indication to treatment with radiotherapy
- Ineligibility or unresponsiveness to systemic cancer treatment
- Maximum tumor depth (from the skin layer): 3 cm
Key exclusion criteria (9 listed)
- History of allergic reaction to bleomycin
- Exceeding the maximum cumulative dose of bleomycin (250,000 IU / m2)
- Severe impairment of lung, liver or kidney function
- History of epilepsy
- Presence of a cardiac pacemaker
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 |
|---|---|---|
| Electrochemotherapy (ECT)Electrochemotherapy (ECT) is characterized by the association between the administration of a chemotherapic agent (Bleomycin) with the temporary raise of permeability of the cellular membrane induced by the local administration of electrical impulses (electroporation). ECT represents an effective therapy for loco-regional control of this disease. | Device | Breast Cancer patients with cutaneous and/or subcutaneous histologically confirmed metastases |
| BleomycinElectrochemotherapy (ECT) is characterized by the association between the administration of a chemotherapic agent (Bleomycin) with the temporary raise of permeability of the cellular membrane | Drug | Breast Cancer patients with cutaneous and/or subcutaneous histologically confirmed metastases |
Primary outcome
Local response
Time frame: 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
Time frame: 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).
3 secondary outcomes
Local progression-free survival (LPFS)
Time frame: 1, 2 , 3 , 6 and 12 months (through study completion, an average of 1 year).
Quality of life and pain relief
Time frame: 1 and 2 weeks, and at 1, 2, 3, 6 and 12 months
Quality of life and pain relief
Time frame: 1 and 2 weeks, and at 1, 2, 3, 6 and 12 months
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 12 Nov 2024.
- Background: PubMed 24251266Wong CY, Helm MA, Kalb RE, Helm TN, Zeitouni NC. The presentation, pathology, and current management strategies of cutaneous metastasis. N Am J Med Sci. 2013 Sep;5(9):499-504. doi: 10.4103/1947-2714.118918.
- Background: PubMed 21074876Zagar TM, Higgins KA, Miles EF, Vujaskovic Z, Dewhirst MW, Clough RW, Prosnitz LR, Jones EL. Durable palliation of breast cancer chest wall recurrence with radiation therapy, hyperthermia, and chemotherapy. Radiother Oncol. 2010 Dec;97(3):535-40. doi: 10.1016/j.radonc.2010.10.020. Epub 2010 Nov 11.
- Background: PubMed 20146568Oldenborg S, Van Os RM, Van rij CM, Crezee J, Van de Kamer JB, Rutgers EJ, Geijsen ED, Zum vorde sive vording PJ, Koning CC, Van tienhoven G. Elective re-irradiation and hyperthermia following resection of persistent locoregional recurrent breast cancer: A retrospective study. Int J Hyperthermia. 2010;26(2):136-44. doi: 10.3109/02656730903341340.
- Background: PubMed 22731832Matthiessen LW, Johannesen HH, Hendel HW, Moss T, Kamby C, Gehl J. Electrochemotherapy for large cutaneous recurrence of breast cancer: a phase II clinical trial. Acta Oncol. 2012 Jul;51(6):713-21. doi: 10.3109/0284186X.2012.685524. Epub 2012 Jun 26.
- Background: PubMed 7504576Belehradek M, Domenge C, Luboinski B, Orlowski S, Belehradek J Jr, Mir LM. Electrochemotherapy, a new antitumor treatment. First clinical phase I-II trial. Cancer. 1993 Dec 15;72(12):3694-700. doi: 10.1002/1097-0142(19931215)72:123.0.co;2-2.
- Background: PubMed 9655305Heller R, Jaroszeski MJ, Reintgen DS, Puleo CA, DeConti RC, Gilbert RA, Glass LF. Treatment of cutaneous and subcutaneous tumors with electrochemotherapy using intralesional bleomycin. Cancer. 1998 Jul 1;83(1):148-57. doi: 10.1002/(sici)1097-0142(19980701)83:13.0.co;2-w.
- Background: PubMed 11440782Rodriguez-Cuevas S, Barroso-Bravo S, Almanza-Estrada J, Cristobal-Martinez L, Gonzalez-Rodriguez E. Electrochemotherapy in primary and metastatic skin tumors: phase II trial using intralesional bleomycin. Arch Med Res. 2001 Jul-Aug;32(4):273-6. doi: 10.1016/s0188-4409(01)00278-8.
- BackgroundMir, LM, Gehl J, Sersa G, et al. Standard operatimg procedures of the electrochemotherapy: instructions for the use of bleomycin or cisplatin administered either systemically or locally and electric pulses delivered by the CliniporatorTM by means of invasive or non-invasive electrodes. Eur J Cancer 2006; 4(suppl 11):14-25
- BackgroundMarty M, Sersa G, Garbay JR, et al. Electrochemotherapy - an easy, highly effective and safe treatment of cutaneous and subcutaneous metastases. Results of ESOPE (European Standard Operating Procedures of Electrochemotherapy) study. European Journal of Cancer Supplements 4 (2006) 3-13.
- Background: PubMed 25154827Spratt DE, Gordon Spratt EA, Wu S, DeRosa A, Lee NY, Lacouture ME, Barker CA. Efficacy of skin-directed therapy for cutaneous metastases from advanced cancer: a meta-analysis. J Clin Oncol. 2014 Oct 1;32(28):3144-55. doi: 10.1200/JCO.2014.55.4634. Epub 2014 Aug 25.
- Background: PubMed 26242370Cabula C, Campana LG, Grilz G, Galuppo S, Bussone R, De Meo L, Bonadies A, Curatolo P, De Laurentiis M, Renne M, Valpione S, Fabrizio T, Solari N, Guida M, Santoriello A, D'Aiuto M, Agresti R. Electrochemotherapy in the Treatment of Cutaneous Metastases from Breast Cancer: A Multicenter Cohort Analysis. Ann Surg Oncol. 2015 Dec;22 Suppl 3:S442-50. doi: 10.1245/s10434-015-4779-6. Epub 2015 Aug 5.
- Background: PubMed 22821399Campana LG, Valpione S, Falci C, Mocellin S, Basso M, Corti L, Balestrieri N, Marchet A, Rossi CR. The activity and safety of electrochemotherapy in persistent chest wall recurrence from breast cancer after mastectomy: a phase-II study. Breast Cancer Res Treat. 2012 Aug;134(3):1169-78. doi: 10.1007/s10549-012-2095-4. Epub 2012 Jul 24.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analysed during the current study are/will be available upon request from Prof.Marco Rastrelli (marco.rastrelli@unipd.it)
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Breast Cancer Metastatic, run by Istituto Oncologico Veneto 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 9 inclusion and 9 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 12 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?
Local response (time frame: 4 and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06683404, which also lists 18 linked publications.
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 12 Nov 2024.