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
| ISRCTN | ISRCTN91258120 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91258120 |
| Secondary identifying numbers | C121 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 04/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Multicentre randomised double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | 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 initially once daily (two drops per 10 cm surface area, allowing for an approximately 3 cm margin around the visible lesion). Provided this has good tolerability the dose will be escalated to twice daily applications from week two onwards. In the absence of clear progression of skin lesions or dose-limiting adverse events a minimum treatment time of eight weeks is suggested. Patients who have a complete response should continue at the same dosage, if possible, for at least a further four weeks after the complete response is observed. Patients will be treated and/or followed-up until progression or occurrence of skin lesions within the treated area, treatment stop due to poor tolerability of the study medication, or necessity for a change in systemic therapy. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Miltefosine |
| Primary outcome measure | Added 06/08/09: Time to treatment failure |
| Secondary outcome measures | Added 06/08/09 1. Rate of response 2. Cutaneous reactions |
| Overall study start date | 01/01/1998 |
| Completion date | 30/04/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/1998 |
| Date of final enrolment | 30/04/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
| Phone | +44 (0)207 317 5186 |
|---|---|
| kate.law@cancer.org.uk | |
| Website | http://www.cancer.org.uk |
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2001 | Yes | No |
