Ceramide Cream in Treating Women With Cutaneous Breast Cancer

OBJECTIVES: I. Determine the objective response rate in women with cutaneous breast cancer
treated with topical ceramide cream. II. Determine the time to progression in patients
treated with this regimen. III. Determine the toxicity of this regimen in these patients.
IV. Assess the quality of life of these patients treated with this regimen.

OUTLINE: Topical ceramide cream is applied to all cutaneous lesions twice daily. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality
of life is assessed at baseline and then at 1 and 3 months. Patients are followed every 3
months for 1 year and then every 6 months for 4 years.

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed cutaneous breast cancer
for which no curative or significantly palliative therapy exists including chest wall
radiotherapy Measurable disease Disease progression after at least 1 hormonal therapy for
estrogen receptor positive disease and after radiotherapy if chest wall disease has been
previously irradiated No infection at site of cutaneous metastatic disease Hormone
receptor status: Estrogen receptor status known

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: ECOG 0-3 Life expectancy: At least 12 weeks Hematopoietic: Not
specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy during first 2
months of study Chemotherapy: No other concurrent local antineoplastic therapy for
cutaneous disease No concurrent systemic chemotherapy during first 2 months of study
Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics
At least 4 weeks since prior radiotherapy No concurrent radiotherapy during first 2 months
of study except for CNS disease Surgery: Not specified