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Bethesda, Maryland 20892


This is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral 9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the regimen. Patients continue treatment for up to 28 weeks, with tamoxifen continued after the study if medically appropriate.

Study summary:

This is a Phase I study of the combination tamoxifen and 9-cis-Retinoic acid in patients with breast cancer. The primary objective of the study is; 1) to determine the maximum tolerated dose of 9-cis-Retinoic acid in combination with Tamoxifen and to determine the overall and dose limiting toxicities. Other objectives are: 2) to determine the effect of Tamoxifen on the pharmacokinetics of 9-cis-Retinoic acid; 3) to evaluate the anti-tumor activity of this combination therapy within the context of a phase I study; 4) and to determine the expression of surrogate biomarkers of breast carcinogenesis before and after treatment.


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.



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Bethesda, Maryland 20892
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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