Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Patients are randomised to receive either:
1. Treatment A: Miltefosine, a 6% solution
2. Treatment B: Placebo solution
The solution whether placebo or miltefosine is applied to the affected area init
Sponsors
Cancer Research UK (CRUK) (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female, aged more than 18 years 2. Histologically or cytologically confirmed breast cancer with inoperable lesions, unsuitable for radiotherapy, inadequately manageable by radiotherapy or systemic endocrine or chemotherapy 3. Superficial nodular or "flat" skin lesions including (estimated depth 1 cm), at least one bidimensionally measurable and progressive lesion 4. Patients should have had at least one prior systemic endocrine or chemotherapy. Patients may take concomitant endocrine therapy only (endocrine therapy must have been unchanged for the last 12 weeks if ongoing at the time of study entry) 5. Performance status World Health Organisation (WHO) grade two with life expectancy of at least three months 6. Satisfactory haematological and blood chemistry values
Exclusion criteria
Exclusion criteria: 1. Patients with no measurable lesions, skin lesions with estimated depth over 1 cm, ulcerated skin lesions over 10% of the area to be treated or local infection within the treated area 2. Clinical evidence of brain metastases that would limit life expectancy to less than six months 3. Patients with progressive associated systemic metastases 4. Previous malignancies within the last five years, except treated and cured carcinoma in situ of the cervix, non-melanoma skin cancer or cutaneous lymphepithelioma 5. Radiotherapy to skin lesions or chemotherapy within the last four weeks 6. Major surgery within the last two weeks 7. Uncontrolled clinically significant illness not related to cancer The only permissible concomitant therapies are irradiation of non-skin lesions for symptom relief and endocrine therapy if it has remained unchanged for at least 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added 06/08/09: Time to treatment failure | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 06/08/09 1. Rate of response 2. Cutaneous reactions | — |
Countries
United Kingdom
Outcome results
None listed