Trial Outcomes & Findings for Radiologic Evaluation and Breast Density (READ) (NCT NCT00117663)

NCT ID: NCT00117663

Last Updated: 2024-04-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1704 participants
• Primary outcome timeframe: 4 years
• Results posted on: 2024-04-04

Participant Flow

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.

Participant milestones

Measure	No Hormone Suspension No hormone suspension prior to screening mammogram	1 Month Hormone Suspension 1 month of hormone suspension prior to screening mammogram	2 Month Hormone Suspension discontinuation of hormone therapy for 2 months prior to screening mammogram.
Overall Study STARTED	567	570	567
Overall Study COMPLETED	542	478	451
Overall Study NOT COMPLETED	25	92	116

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiologic Evaluation and Breast Density (READ)

Baseline characteristics by cohort

Measure	No Hormone Suspension n=567 Participants No hormone suspension prior to screening mammogram	1 Month Hormone Suspension n=570 Participants 1 month of hormone suspension prior to screening mammogram	2 Month Hormone Suspension n=567 Participants discontinuation of hormone therapy for 2 months prior to screening mammogram.	Total n=1704 Participants Total of all reporting groups
Age, Customized 45 - 80 years	567 participants n=5 Participants	570 participants n=7 Participants	567 participants n=5 Participants	1704 participants n=4 Participants
Sex: Female, Male Female	567 Participants n=5 Participants	570 Participants n=7 Participants	567 Participants n=5 Participants	1704 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	567 participants n=5 Participants	570 participants n=7 Participants	567 participants n=5 Participants	1704 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	No Hormone Suspension n=542 Participants Hormone Replacement Therapy (HRT) was not interrupted prior to mammogram in this arm.	1 Month Hormone Suspension n=478 Participants Hormone Replacement Therapy (HRT) was suspended for 1 month prior to mammogram then resumed.	2 Month Hormone Suspension n=451 Participants Hormone Replacement Therapy (HRT) was interrupted for 2 months prior to mammogram then resumed in this arm.
Mammogram Recall for Additional Imaging	11.3 percentage of women recalled Interval 8.7 to 14.2	12.3 percentage of women recalled Interval 9.5 to 15.6	9.8 percentage of women recalled Interval 7.2 to 12.9

PRIMARY outcome

Timeframe: 4 years

Breast density (Mean, SE) and Change in Breast density by Randomization Group

Outcome measures

Measure	No Hormone Suspension n=541 Participants Hormone Replacement Therapy (HRT) was not interrupted prior to mammogram in this arm.	1 Month Hormone Suspension n=478 Participants Hormone Replacement Therapy (HRT) was suspended for 1 month prior to mammogram then resumed.	2 Month Hormone Suspension n=452 Participants Hormone Replacement Therapy (HRT) was interrupted for 2 months prior to mammogram then resumed in this arm.
Mammographic Breast Density	0.1 Change in % dense Standard Error 0.3	-0.9 Change in % dense Standard Error 0.3	-1.5 Change in % dense Standard Error 0.4

Adverse Events

No Hormone Suspension

Serious events: 5 serious events

Other events: 13 other events

Deaths: 0 deaths

1 Month Hormone Suspension

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

2 Month Hormone Suspension

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	No Hormone Suspension n=527 participants at risk No hormone suspension prior to screening mammogram	1 Month Hormone Suspension n=462 participants at risk 1 month of hormone suspension prior to screening mammogram	2 Month Hormone Suspension n=443 participants at risk 2 months of hormone suspension prior to screening mammogram
Cardiac disorders Myocardial Infarction	0.38% 2/527 • Number of events 2	0.00% 0/462	0.00% 0/443
Vascular disorders Stroke	0.19% 1/527 • Number of events 1	0.00% 0/462	0.23% 1/443 • Number of events 1
General disorders Death	0.38% 2/527 • Number of events 2	0.22% 1/462 • Number of events 1	0.23% 1/443 • Number of events 1

Other adverse events

Measure	No Hormone Suspension n=527 participants at risk No hormone suspension prior to screening mammogram	1 Month Hormone Suspension n=462 participants at risk 1 month of hormone suspension prior to screening mammogram	2 Month Hormone Suspension n=443 participants at risk 2 months of hormone suspension prior to screening mammogram
Reproductive system and breast disorders Breast Cancer	0.57% 3/527 • Number of events 3	0.00% 0/462	0.00% 0/443
Cardiac disorders Atypical Chest Pain	0.38% 2/527 • Number of events 2	0.00% 0/462	0.00% 0/443
General disorders Other adverse event	1.5% 8/527 • Number of events 8	1.3% 6/462 • Number of events 6	0.00% 0/443

Additional Information

Diana Buist PhD, Principal Investigator

Group Health Research Institute

Phone: 206-287-2931

Email: buist.d@ghc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place