Low-Dose Tamoxifen for Radiation-Induced Breast Cancer Risk Reduction: A Phase IIB Randomized Placebo-Controlled Trial
PRIMARY OBJECTIVES:
I. To determine the impact of a two-year course of low-dose tamoxifen (tamoxifen citrate)
administered at 5 mg per day on surrogate endpoint biomarkers of breast cancer (BC) risk,
including: mammographic breast density (MBD), an established radiographic biomarker of BC
risk; cytomorphology and proliferative index, tissue biomarkers closely linked to BC risk;
and sex steroid hormones and insulin growth factors, circulating biomarkers of BC risk.
II. To establish safety and tolerability of this low-dose tamoxifen regimen, assessing both
objective measures (lipid profiles, clotting factors and bone metabolism markers) and
patient-reported outcomes.
III. To examine the modifying effect of demographic, clinical, and molecular characteristics
on the risk: benefit ratio from this two-year low dose tamoxifen intervention.
IV. To explore the relationship between this low-dose tamoxifen regimen and clinical
measures of efficacy (new breast cancer and DCIS diagnoses) and toxicity (thromboembolic
events, reports of hot flashes and gynecological symptoms, liver function abnormalities, and
other cancer diagnoses).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive tamoxifen citrate orally (PO) once daily for 24 months in the
absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO once daily for 24 months in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Efficacy of low dose tamoxifen citrate in reducing mammographic breast density
Madena Software System
At year two post treatment
Yes
Melanie R. Palomares, MD, MS
Principal Investigator
City of Hope Medical Center
United States: Food and Drug Administration
08218
NCT01196936
September 2010
May 2016
Name | Location |
---|---|
University of Michigan | Ann Arbor, Michigan 48109-0624 |
Mayo Clinic | Rochester, Minnesota 55905 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Emory University School of Medicine | Atlanta, Georgia 30322 |
City of Hope Medical Center | Duarte, California 91010 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
University of California at Los Angeles (UCLA ) | Los Angeles, California 90095 |