A placebo-controlled, double-blind, multicentre phase III trial to assess the efficacy and safety of miltefosine solution in the treatment of breast cancer where no other appropriate treatment is available

Completed

• Conditions: Breast cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN91258120
• Lead Sponsor: Cancer Research UK (CRUK) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Added 06/08/09:<br>Time to treatment failure

Secondary Outcome Measures

Name	Time	Method
Added 06/08/09<br>1. Rate of response<br>2. Cutaneous reactions