| Methods |
Double‐blind, placebo controlled, multi‐centred trial. |
| Participants |
52 female patients, > 18 years old. Inclusion criteria: confirmed breast cancer with superficial, or flat, skin lesions where the estimated depth of invasion below skin level was ≤ 1cm. All participants had received at least 1 prior systemic endocrine or chemotherapy treatment. Participants required adequate bone marrow status, and renal and hepatic function, to ensure that those at risk of requiring systemic therapeutic interventions ‐ due to concomitant or incipient visceral disease ‐ were excluded. Exclusion criteria: skin lesions manageable with surgery, radiotherapy, systemic endocrine therapy or chemotherapy; progressive systemic metastases, or other malignancies within the last five years (except treated and cured cervical carcinoma in situ, non melanoma skin cancer or cutaneous lymphoepithelioma); recent major surgery; concomitant treatment with other investigational drugs; uncontrolled clinically‐significant non‐cancer medical illness; and those who were lactating, pregnant, or had childbearing potential and were not taking adequate contraceptive precautions. |
| Interventions |
6% miltefosine solution 2 drops/10 cm2 of skin area including the affected skin and a margin of 3cm around each lesion, once daily during first week and twice daily thereafter. |
| Outcomes |
Quality of life.
Tumour containment/remission. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
The report states that this is a 'placebo controlled ...trial' but the method of generating the randomisation sequence was not described. |
| Allocation concealment (selection bias) |
Unclear risk |
not reported |
| Blinding (performance bias and detection bias)
outcome assessment |
Low risk |
Participants, clinicians and outcome assessors were blinded. ("The placebo was plyethene glycol solution, having a similar appearance and viscosity" and "All responses were assessed by an independent reviewer before the randomization codes were unblinded.") |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
The report states that an ITT analysis was conducted. There were 9 withdrawals. |
