Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Hormone Suspension | No Intervention | No hormone suspension prior to screening mammogram | |
| 1 month hormone suspension | Active Comparator | discontinuation of hormone therapy for 1 month prior to screening mammogram. |
|
| 2 month hormone suspension | Active Comparator | discontinuation of hormone therapy for 2 months prior to screening mammogram. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temporary discontinuation of hormone therapy for 1 month | Other | temporary discontinuation of hormone replacement therapy for 1 month prior to screening mammogram. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mammogram Recall for Additional Imaging | Mammography recall was defined as any assessment requiring additional imaging or evaluation of either breast (BI-RADS assessment of 0 for either or both breasts)(30) determined exclusively from the study radiologists' interpretation. | 4 years |
| Mammographic Breast Density | Breast density (Mean, SE) and Change in Breast density by Randomization Group | 4 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Diana SM Buist, Ph.D. | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Group Health Research Institute | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21813728 | Derived | 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. | |
| 20979462 | Derived | 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. |
| Label | URL |
|---|---|
| Link for patients | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
1704 women age 45 to 80 years who used hormone therapy at their most recent screening (index) mammography, were due for screening (study) mammography, and were still using hormone therapy.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | No Hormone Suspension | No hormone suspension prior to screening mammogram |
| FG001 | 1 Month Hormone Suspension | 1 month of hormone suspension prior to screening mammogram |
| FG002 | 2 Month Hormone Suspension | discontinuation of hormone therapy for 2 months prior to screening mammogram. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | No Hormone Suspension | No hormone suspension prior to screening mammogram |
| BG001 | 1 Month Hormone Suspension | 1 month of hormone suspension prior to screening mammogram |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mammogram Recall for Additional Imaging | Mammography recall was defined as any assessment requiring additional imaging or evaluation of either breast (BI-RADS assessment of 0 for either or both breasts)(30) determined exclusively from the study radiologists' interpretation. | Posted | Number | 95% Confidence Interval | percentage of women recalled | 4 years |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Hormone Suspension | No hormone suspension prior to screening mammogram |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Cancer | Reproductive system and breast disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana Buist PhD, Principal Investigator | Group Health Research Institute | 206-287-2931 | buist.d@ghc.org |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| temporary discontinuation of hormone therapy for 2 months | Other | temporary discontinuation of hormone replacement therapy for 2 months prior to screening mammogram |
|
| 20575711 | Derived | 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. |
| 19455069 | Derived | 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. |
| BG002 | 2 Month Hormone Suspension | discontinuation of hormone therapy for 2 months prior to screening mammogram. |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| 2 Month Hormone Suspension |
Hormone Replacement Therapy (HRT) was interrupted for 2 months prior to mammogram then resumed in this arm. |
|
|
| Primary | Mammographic Breast Density | Breast density (Mean, SE) and Change in Breast density by Randomization Group | Posted | Mean | Standard Error | Change in % dense | 4 years |
|
|
|
| 5 |
| 527 |
| 13 |
| 527 |
| EG001 | 1 Month Hormone Suspension | 1 month of hormone suspension prior to screening mammogram | 1 | 462 | 6 | 462 |
| EG002 | 2 Month Hormone Suspension | 2 months of hormone suspension prior to screening mammogram | 2 | 443 | 0 | 443 |
| Stroke | Vascular disorders |
|
| Death | General disorders |
|
| Atypical Chest Pain | Cardiac disorders |
|
| Other adverse event | General disorders |
|
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |