A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients
NCT00001504 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2008-03-04
Summary
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.
Conditions
- Breast Cancer
- Breast Neoplasm
Interventions
- DRUG
-
9-cis-Retinoic Acid
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Study Design
- Purpose
- TREATMENT
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1996-05-31
- Completion
- 2002-01-31
Countries
- United States
Study Locations
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