Breast Cancer Clinical Trial
Official title:
A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients
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.
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. ;
Endpoint Classification: Safety Study, Primary Purpose: Treatment
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