A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients

You may be eligible if

• DISEASE CHARACTERISTICS:
• All patients must have histologically documented diagnosis of Stage III, or IV breast carcinoma.
• Patients with stage III that has completed chemotherapy: Estrogen receptor (ER) or progesterone receptor (PR) positive tumor required if premenopausal. Either ER/PR-positive or -negative tumor allowed if postmenopausal and have received prior chemotherapy.
• Patients may have stage IV with ER/PR-positive or -negative tumor.
• No CNS metastases, pseudotumor cereri, or seizures.
• PRIOR/CONCURRENT THERAPY:
• Patients who have ecovered from the toxic effects of prior therapy will be eligible.
• Patients with prior tamoxifen will be allowed to participate. At least 3 weeks must have elapsed since the last dose of chemotherapy.
• PATIENT CHARACTERISTICS:
• Age: 18 and over.
• Sex: Men and women.
• Menopausal status: Any status.
• Patients must have a performance status of ECOG 0-2.
• Patients must have Hematopoietic criteria of:
• ANC at least 1,500/mm(3).
• Platelet count at least 90,000/mm(3).
• Patients must have Hepatic criteria of:
• In the absence of tumor involvement:
• Bilirubin no greater than twice normal;
• SGOT no greater than twice normal;
• Alkaline phosphate no greater than twice normal;
• Fasting triglycerides less than 3 times normal.
• Patients must have Renal criteria of:
• Serum creatinine no greater than 1.5 mg/dL OR;
• Creatinine clearance at least 60 mL/min.
• Other:
• No allergy to study medications.
• No nonmalignant systemic disease that would preclude therapy.
• No second malignancy within 5 years except: Curatively treated basal cell skin carcinoma. Cervical carcinoma in situ.
• Pregnant women will be excluded.
• Negative pregnancy test required within 7 days prior to entry.
• Adequate contraception required for 4 weeks prior to, during, and for 1 year after study.
• Patients must give informed consent.
• Patients who are poor medical or psychiatric risks will be eligible.