Cutaneous metastases from breast cancer Cancer
Conditions
Interventions
Patients will be enrolled based on the inclusion criteria currently employed in the clinical practice. The percentage of women with "luminal A-like" breast cancer in the previous, retrospective study
the patients will have to stay in hospital 4-6 hours after the procedure or until the following day, according to their general conditions and specific requirements. After discharge, the patients will
Sponsors
Veneto Institute of Oncology IOv-IRCCS
University of Padova
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Local response to the treatment, assessed using clinical examination and graded according to the Response Evaluation Criteria In Solid Tumors (RECIST) at 4 and 8 weeks 2. Treatment toxicity, assessed using clinical examination and graded according to the Common Terminology Criteria for Adverse Events (CTCAE v4.0) at 1 and 2 weeks and 1, 2, 3, 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Local progression-free survival (LPFS), assessed using physical examination at 1, 2 , 3 , 6 and 12 months (and every 6 months thereafter) 2. Quality of life, measured using the EQ-5D questionnaire at 1 and 2 weeks, and at 1, 2, 3, 6 and 12 months | — |
Countries
Italy
Outcome results
None listed