Breast cancer that has spread to the skin MedDRA version: 14.0 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Bleomycin
Product Name: Bleomycin
Product Code: 11056-06-7
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: bleomycin
CAS Number: 11056-06-7
Current Sponsor code:
Sponsors
Department of Oncology University Hospital Uppsala
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients > 18 years of age • Histological confirmed breast cancer • Metastatic breast cancer (skin lesions only are considered as metastatic disease) • Prior histological confirmation of at least one skin lesion • Skin lesions must not have a depth greater than 3 cm (measured clinically if possible otherwise on the basis of CT/ultrasound examination • Confluent skin metastases where individual lesions are hard to define in their entirety may not exceed a maximum area of 10 x 10 cm for each area of confluence. If there are several areas of confluence, the patient may be included in the study provided that all lesions can be treated within the time constraints of a single ECT session (20 minutes). • Not more than ten skin lesions. Each area of confluence is considered as one lesion. • A single skin lesion may not exceed 5 cm • Patients may not have received more than one line of systemic treatment (chemotherapy or endocrine therapy) for metastatic disease following the discovery of skin metastases. Patients developing skin metastases for the first time during ongoing systemic therapy may receive one additional line of systemic treatment prior to inclusion. • Patients in the early ECT arm may receive any other cancer treatments at the discretion of the treating physician starting no earlier than 2 weeks following ECT. This is to ensure that patients with metastatic disease in other locations will receive treatment that is considered suitable regardless of their participation in this trial. (If 2 weeks from ECT to the start of systemic treatment is judged to be too long by the treating physician, this patient should not be entered into the trial). • Women of childbearing age must practice a suitable form of contraception. • Patients must be willing to comply with the study protocol and give their written informed consent. • A life expectancy of at least 6 months. • Patients with a ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • Patients who have extensive and rapidly progressive visceral metastases where a delay in systemic therapy by eventual ECT is judged to not be in the patients` best interest • Patients, who for medical reasons, cannot be given bleomycin • Patients with brain metastases treated with surgery and/or radiotherapy who have progressive disease in the brain two months after treatment • Prior cumulative dose of bleomycin exceeding 250,000 IU/m2 • Less than 14 days from previous cancer treatment (either local or systemic) • If the patient has skin lesions that are situated in close proximity to a pacemaker such that an electrical field from ECT will overlap the pacemaker, the pacemaker must be moved to another location in order for the patient to be able to participate in the study • Chronic renal failure (serum creatinine > 150?mol/L) • Inadequate liver function defined as: ? ASAT or ALAT > 2.5 x ULN in the absence of liver metastases or > 5 in the presence of liver metastases ? or Bilirubin > 2 x ULN (except in the case of Gilberts Syndrome) ? or Albumin < 25 g/L • Inadequate bone marrow reserve defined as: ? White blood cell count < 3 X 109/L or Neutrophil count < 1.5 X109/L or Platelet count < 100 X 109/L • Any severe uncontrolled systemic disease. • Unable or unwilling to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is a comparison of treatment strategies rather than single treatment modalities. The main objective is to determine if there is an advantage to giving ECT at an earlier stage in the treatment of cutaneous metastatic breast cancer compared to the usual practice of using ECT when all other treatment options have been exhausted. A potential advantage to early ECT treatment may be defined from several aspects: improved local control of metastatic growth, improved quality of life based on potentially less systemic therapy and finally health economic advantages because there is a potential for patients to delay or avoid systemic treatments if there is good local control;Secondary Objective: -Local control of skin metastases over the period of six to eighteen months of follow-up. -Time to local treatment failure -Response of target lesions -Quality of Life using Fact B and EQ5d questionnaire -Retrospective health economic analysis for the two treatment arms -Comparison in the two study arms with respect to the types of therapy, number of changes in therapies, the number of cycles of chemotherapy and duration of endocrine therapies during the 18 months of follow-up. Overall survival Serious Adverse Events An assessment of pain in patients receiving ECT using the Short McGill Pain Score ;Primary end point(s): Local control of skin metastases at six months of follow-up;Timepoint(s) of evaluation of this end point: 6 months following randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Local control of skin metastases over the period of six to eighteen months of follow-up. • Time to local treatment failure • Response of target lesions • Quality of Life using Fact B and EQ5d questionnaire • Retrospective health economic analysis for the two treatment arms • Comparison in the two study arms with respect to the types of therapy, number of changes in therapies, the number of cycles of chemotherapy and duration of endocrine therapies during the 18 months of follow-up. • Overall survival • Serious Adverse Events • An assessment of pain in patients receiving ECT using the Short McGill Pain Score ;Timepoint(s) of evaluation of this end point: six to eighteen months after randomization Overall survival up to 24 months after randomization | — |
Countries
Sweden
Contacts
Public ContactJeffrey Yachnin
Department of Oncology University Hospital Uppsala
Outcome results
None listed