GISEL:Registry of Breast Cancer Patients Treated With ECT

NCT06683404 | Completed DMC

• 1 other identifier: Cod. Int. CE IOV 2017/11
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Cancer Metastatic; Breast Cancer Recurrent

Keywords

bleomycin; breast cancer; breast cancer cutaneous and subcutaneous metastasis; electrochemotherapy; breast cancer treatment; electroporation

Outcome Measures

Primary Outcomes (2)

• Local response

  Local response to the treatment, assessed using clinical examination and graded according to the Response Evaluation Criteria In Solid Tumors (RECIST).

  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).

  1 and 2 weeks and 1, 2, 3, 6 and 12 months

Secondary Outcomes (3)

• Local progression-free survival (LPFS)

  1, 2 , 3 , 6 and 12 months (through study completion, an average of 1 year).

• Quality of life and pain relief

  1 and 2 weeks, and at 1, 2, 3, 6 and 12 months

• Quality of life and pain relief

  1 and 2 weeks, and at 1, 2, 3, 6 and 12 months

Study Arms (1)

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.

Device: Electrochemotherapy (ECT); Drug: Bleomycin

Interventions

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.

Breast Cancer patients with cutaneous and/or subcutaneous histologically confirmed metastases

Bleomycin DRUG

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

Breast Cancer patients with cutaneous and/or subcutaneous histologically confirmed metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Normal hematology, hepatic and renal function
• Performance status (ECOG) ≤2
• At least 18 years old

You may not qualify if:

• 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
• Pregnancy or lactation
• Unwillingness to attend the clinic for follow-up visits
• Impaired respiratory function or presence of pulmonary fibrosis -

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS: lead

Study Sites (1)

Veneto Institute of Oncology IRCCS

Padua, 35128, Italy

Location

Related Publications (18)

• 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.

  PMID: 24251266 BACKGROUND

• Zagar 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.

  PMID: 21074876 BACKGROUND

• Oldenborg 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.

  PMID: 20146568 BACKGROUND

• Matthiessen 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.

  PMID: 22731832 BACKGROUND

• Belehradek 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.

  PMID: 7504576 BACKGROUND

• Heller 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.

  PMID: 9655305 BACKGROUND

• Rodriguez-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.

  PMID: 11440782 BACKGROUND

• Mir, 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25154827 BACKGROUND

• Cabula 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.

  PMID: 26242370 BACKGROUND

• Campana 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.

  PMID: 22821399 BACKGROUND

• Benevento 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.

  PMID: 23173816 BACKGROUND

• Solari 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.

  PMID: 24165992 BACKGROUND

• Mali 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.

  PMID: 22980492 BACKGROUND

• Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.

  PMID: 10655437 BACKGROUND

• Goldhirsch A, Wood WC, Coates AS, Gelber RD, Thurlimann B, Senn HJ; Panel members. Strategies for subtypes--dealing with the diversity of breast cancer: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann Oncol. 2011 Aug;22(8):1736-47. doi: 10.1093/annonc/mdr304. Epub 2011 Jun 27.

  PMID: 21709140 BACKGROUND

• Russano F, Corrado G, Bonadies A, Migliano E, di Giacomo R, Esposito E, Zamagni C, Ala A, Campana L, Fabrizio T, Ghilli M, Palli D, Renne M, Cabula R, Pelle F, Silvestri B, Dieci MV, Guarneri V, Rastrelli M. Prospective multicentre study of patients with cutaneous metastases from breast cancer treated with electrochemotherapy. Clin Exp Metastasis. 2025 May 29;42(4):32. doi: 10.1007/s10585-025-10350-5.

  PMID: 40439892 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Electrochemotherapy; Bleomycin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Electroporation Therapies; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: November 12, 2024
• Study Start: April 22, 2016
• Primary Completion: October 21, 2021
• Study Completion: December 10, 2022
• Last Updated: November 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Access Criteria: Available on request

Locations

IT (1)