CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 501 enrolled
Drug / intervention
tamoxifen citrate +4 moredrug
Likely dose
tamoxifen citrate 40 mgfrom 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.

Search/NCT00764322
NCT00764322Phase 2Completed
CompareCT.gov

Validating CYP2D6 Genotype-Guided Tamoxifen Therapy for a Multiracial U.S. Population

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Oct 2, 2008·Updated Aug 1, 2017

In Brief

A Phase 2 clinical trial evaluating tamoxifen citrate, gene expression analysis, and 3 other interventions for Breast Cancer and Menopausal Symptoms. Completed, enrolled 501 participants across 7 sites.

Detailed Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about differences in DNA and predict how well patients will respond to treatment and plan better treatment. PURPOSE: This clinical trial is studying blood samples from women with breast cancer or ductal carcinoma in situ who are receiving tamoxifen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Menopausal Symptoms
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2, 2008
Enrollment StartJun 18, 2008
Primary CompletionSep 28, 2010
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.8 years ago

Interventions

tamoxifen citratedrug

Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis.

gene expression analysisgenetic

Genetic analysis of blood sample.

pharmacogenomic studiesother

Genetic analysis of blood sample.

questionnaire administrationother

Questionnaire called the survey of participants. Questionnaires is self administered on paper documents and given pre-study, and at 4 months

quality-of-life assessmentprocedure

Self administration of a multiquestion questionnaire called the Functional Assessment of Cancer Therapy -Breast (FACT-B). Given pre-study, at 4 months and at 8-10 months.