At a glance
ClinicalIndex Comparison RecordPhase 1Completed
Drug / intervention
9-cis-Retinoic Aciddrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients
In Brief
A Phase 1 clinical trial evaluating 9-cis-Retinoic Acid for Breast Cancer and Breast Neoplasm. Completed, across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Breast Neoplasm
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 1996
First PostedNov 1999
Study CompletionJan 2002
TodayJul 2026
First PostedNov 4, 1999
Enrollment StartMay 1, 1996
Study CompletionJan 1, 2002
TodayJul 2, 2026
Posted 26.7 years ago
Interventions
9-cis-Retinoic Aciddrug