A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients
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.
Interventional
Endpoint Classification: Safety Study, Primary Purpose: Treatment
United States: Federal Government
960080
NCT00001504
May 1996
January 2002
Name | Location |
---|---|
National Cancer Institute (NCI) | Bethesda, Maryland 20892 |