CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 84 enrolled
Drug / intervention
Tamoxifen Citrate +10 moredrug
Likely dose
Tamoxifen Citrate 5 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/NCT01196936
NCT01196936Phase 2Active
CompareCT.gov

Low-Dose Tamoxifen for Radiation-Induced Breast Cancer Risk Reduction: A Phase IIB Randomized Placebo-Controlled Trial

University of Alabama at Birmingham·interventional·Posted Sep 9, 2010·Updated Jan 5, 2026

In Brief

A Phase 2 clinical trial evaluating Tamoxifen Citrate, Placebo, and 9 other interventions for Breast Cancer. Active but no longer recruiting, targeting 84 participants across 13 sites in 2 countries.

Detailed Summary

Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast cancer risk in radiation-induced cancer survivors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI), St. Jude Children's Research Hospital, University Health Network, Toronto, University of Michigan, Dana-Farber Cancer Institute, Mayo Clinic, University of Washington, City of Hope National Medical Center, M.D. Anderson Cancer Center, University of Chicago, University of Minnesota, University of Colorado, Denver, Wake Forest University

Timeline

Phase 2Active
2011201220132014201520162017201820192020202120222023202420252026202720282029
First PostedSep 9, 2010
Enrollment StartSep 1, 2010
Primary CompletionDec 11, 2018
Study CompletionDec 11, 2028
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 15.8 years ago

Interventions

Tamoxifen Citratedrug

5 mg PO Daily

Placebodrug

1 tablet daily

Digital mammographyprocedure

Correlative studies

immunohistochemistry staining methodother

Correlative Studies

pharmacological studyother

Correlative Studies

laboratory biomarker analysisother

Correlative Studies

protein expression analysisgenetic

correlative studies

pharmacogenomic studiesother

correlative studies

questionnaire administrationother

Ancillary studies

Fine needle aspirationprocedure

Quality of Life Assessmentother

Ancillary Studies