Breast Cancer
Conditions
Keywords
Randomized controlled trial, Mammography, health care setting, hormone replacement therapy, breast density, mammography performance, Breast Carcinoma
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.
Interventions
OTHERtemporary discontinuation of hormone therapy for 1 month
temporary discontinuation of hormone replacement therapy for 1 month prior to screening mammogram.
OTHERtemporary discontinuation of hormone therapy for 2 months
temporary discontinuation of hormone replacement therapy for 2 months prior to screening mammogram
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mammogram Recall for Additional Imaging | 4 years | 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. |
| Mammographic Breast Density | 4 years | Breast density (Mean, SE) and Change in Breast density by Randomization Group |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| No Hormone Suspension No hormone suspension prior to screening mammogram | 567 |
| 1 Month Hormone Suspension 1 month of hormone suspension prior to screening mammogram | 570 |
| 2 Month Hormone Suspension discontinuation of hormone therapy for 2 months prior to screening mammogram. | 567 |
| Total | 1,704 |
Baseline characteristics
| Characteristic | No Hormone Suspension | 1 Month Hormone Suspension | 2 Month Hormone Suspension | Total |
|---|---|---|---|---|
| Age, Customized 45 - 80 years | 567 participants | 570 participants | 567 participants | 1704 participants |
| Region of Enrollment United States | 567 participants | 570 participants | 567 participants | 1704 participants |
| Sex: Female, Male Female | 567 Participants | 570 Participants | 567 Participants | 1704 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 527 | 6 / 462 | 0 / 443 |
| serious Total, serious adverse events | 5 / 527 | 1 / 462 | 2 / 443 |
Outcome results
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.
Time frame: 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Hormone Suspension | Mammogram Recall for Additional Imaging | 11.3 percentage of women recalled |
| 1 Month Hormone Suspension | Mammogram Recall for Additional Imaging | 12.3 percentage of women recalled |
| 2 Month Hormone Suspension | Mammogram Recall for Additional Imaging | 9.8 percentage of women recalled |
Primary
Mammographic Breast Density
Breast density (Mean, SE) and Change in Breast density by Randomization Group
Time frame: 4 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Hormone Suspension | Mammographic Breast Density | 0.1 Change in % dense | Standard Error 0.3 |
| 1 Month Hormone Suspension | Mammographic Breast Density | -0.9 Change in % dense | Standard Error 0.3 |
| 2 Month Hormone Suspension | Mammographic Breast Density | -1.5 Change in % dense | Standard Error 0.4 |