Pilot study on electrochemotherapy in metastatic breast cancer

Phase 1

• Conditions: Metastatic breast cancer during systemic therapy and in disease stability according to RECIST 1.1 criteria; MedDRA version: 20.0Level: LLTClassification code 10006216Term: Breast carcinoma stage IVSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-000458-24-IT
• Lead Sponsor: ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

• Age > 18 years
• Diagnosis of histologically confirmed breast cancer with intraparenchymal breast lesion
• Stability of the disease assessed at the end of three cycles of systemic therapy regardless of the type of drug according to RECIST 1.1 criteria.
• Stage IV of the disease according to TNM (VIII AJCC classification)
• Performance status (PS) according to (ECOG) = 2
• Signature of informed consent
• Patients not randomized to other clinical trials
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

• Carcinomatous Mastitis (IBC - T4d stage)
• Neutrophils <1,000 / ml
• Platelets <70,000 / mL
• Hemoglobin = 9 gr / dl
• Known allergy to Bleomycin
• Cumulative dose of Bleomycin which exceeded 250 mg/m2
• Infection in progress
• Cardiac arrhythmia [severe conduction disorders such as type 2 and type 3 atrioventricular blocks and sino-atrial block]
• History of Epilepsy
• Pregnancy in progress
• Patient unable to read or understand study documents
• Patient with any disease or other significant clinical condition that, in the investigator's judgment, could interfere with the study assessments or with adequate participation in the study.
• Patient in progression of the disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified