Clinical trial NCT00117663: Radiologic Evaluation and Breast Density (READ)
Official title: A Population-Based Randomized Trial to Assess the Effects of Short-Term Cessation of Hormone Replacement Therapy (HRT) on Mammography Assessments and Breast Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Randomized controlled trial
Mammography
health care setting
hormone replacement therapy
breast density
mammography performance
Breast Carcinoma
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2005-07-08
Enrollment: 1704
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether cessation of hormone replacement therapy for one or two months before a screening mammogram will improve its performance by decreasing breast density.

Detailed description: This randomized, controlled trial is designed to test whether short-term (1-2 months) HRT cessation will sufficiently lower breast density to decrease the proportion of women who receive a recommendation for additional evaluation following a screening mammogram, and to examine whether there is a trend by duration of cessation. The study is being conducted at Group Health Cooperative, a managed health care organization in western Washington State with an organized breast cancer screening program. We are recruiting 1,500 women and will randomize women to one of three HRT arms: 1) cessation two months before the screening mammogram; 2) cessation one month before; and 3) continued HRT use. We are using a computer-assisted method to measure mammographic breast density continuously. Mammography recall rates are being determined from an expert radiologist review of the mammograms, blinded to HRT status.

Eligibility criteria: Inclusion Criteria:

* 1 or more prior screening mammograms at Group Health Cooperative within the past 2 years
* Currently taking HRT
* Taking HRT at prior screening mammogram
* Due for a screening mammogram

Exclusion Criteria:

* BI-RADS breast density of 1 (entirely fat)
* Previous cardiovascular events (heart surgery, catheterization, stent bypass, angioplasty, stroke, DVT)
* Previous breast cancer
* History of breast implants
* Breast reduction since last mammogram
* Mastectomy
* History of using Tamoxifen or Raloxifene
* Declined contact or use of data for research

Primary outcomes:
measure: Mammogram Recall for Additional Imaging
timeFrame: 4 years
measure: Mammographic Breast Density
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Diana SM Buist, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lowry SJ, Aiello Bowles EJ, Anderson ML, Buist DS. Predictors of breast density change after hormone therapy cessation: results from a randomized trial. Cancer Epidemiol Biomarkers Prev. 2011 Oct;20(10):2309-12. doi: 10.1158/1055-9965.EPI-11-0629. Epub 2011 Aug 3.
citation: Newton KM, Anderson ML, Reed SD, Bowles EJ, Buist DS. Factors associated with non-compliance with hormone therapy cessation before screening mammography. Climacteric. 2011 Apr;14(2):268-74. doi: 10.3109/13697137.2010.520172. Epub 2010 Oct 27.
citation: Aiello Bowles EJ, Anderson ML, Reed SD, Newton KM, Fitzgibbons ED, Seger D, Buist DS. Mammographic breast density and tolerance for short-term postmenopausal hormone therapy suspension. J Womens Health (Larchmt). 2010 Aug;19(8):1467-74. doi: 10.1089/jwh.2009.1681.
citation: Reed SD, Buist DS, Anderson ML, Bowles EJ, Fitzgibbons D, Seger D, Newton KM. Short-term (1-2 mo) hormone therapy cessation before mammography. Menopause. 2009 Nov-Dec;16(6):1125-31. doi: 10.1097/gme.0b013e3181a5ce60.