Breast CancerNCT00117663
Radiologic Evaluation and Breast Density (READ)
A study testing temporary discontinuation of hormone therapy for 1 month and temporary discontinuation of hormone therapy for 2 months in people with Breast Cancer, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- temporary discontinuation of hormone therapy for 1 month and temporary discontinuation of hormone therapy for 2 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,704 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Nov 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Group Health Research Institute
Seattle, Washington, 98101
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- temporary discontinuation of hormone therapy for 1 month, temporary discontinuation of hormone therapy for 2 months
- Keywords
- Randomized controlled trial, Mammography, health care setting, hormone replacement therapy, breast density, mammography performance, Breast Carcinoma
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temporary discontinuation of hormone therapy for 1 monthOther
temporary discontinuation of hormone replacement therapy for 1 month prior to screening mammogram.
temporary discontinuation of hormone therapy for 2 monthsOther
temporary discontinuation of hormone replacement therapy for 2 months prior to screening mammogram
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: temporary discontinuation of hormone therapy for 1 month |
| 2 month hormone suspension | Active comparator | discontinuation of hormone therapy for 2 months prior to screening mammogram. Receives: Other: temporary discontinuation of hormone therapy for 2 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Mammographic Breast Density
Breast density (Mean, SE) and Change in Breast density by Randomization Group
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2005 (estimated)
- Study startNov 2004
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,704 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana SM Buist, Ph.D., Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117663
- Sponsor's protocol ID
- DAMD17-03-1-0447
- Status last verified
- Mar 2024
- First submitted
- 30 Jun 2005
- Last updated
- 4 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21813728Newton 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.
PubMed 20979462Aiello 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.
PubMed 20575711Reed 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.
PubMed 19455069
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00117663
- Acronym / sponsor ID
- DAMD17-03-1-0447
- Conditions
- Breast Cancer
- Keywords
- Randomized controlled trial, Mammography, health care setting, hormone replacement therapy, breast density, mammography performance, Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,704 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 8 Jul 2005 (estimated)
- Results
- Posted 4 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Hormone Suspension | No intervention | –No hormone suspension prior to screening mammogram |
| 1 month hormone suspension | Active comparator | Other: temporary discontinuation of hormone therapy for 1 monthdiscontinuation of hormone therapy for 1 month prior to screening mammogram. |
| 2 month hormone suspension | Active comparator | Other: temporary discontinuation of hormone therapy for 2 monthsdiscontinuation of hormone therapy for 2 months prior to screening mammogram. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temporary discontinuation of hormone therapy for 1 monthtemporary discontinuation of hormone replacement therapy for 1 month prior to screening mammogram. | Other | 1 month hormone suspension |
| temporary discontinuation of hormone therapy for 2 monthstemporary discontinuation of hormone replacement therapy for 2 months prior to screening mammogram | Other | 2 month hormone suspension |
Primary outcome
Mammogram Recall for Additional Imaging
Time frame: 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
Time frame: 4 years
Breast density (Mean, SE) and Change in Breast density by Randomization Group
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21813728Lowry 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.
- Derived from this study: PubMed 20979462Newton 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.
- Derived from this study: PubMed 20575711Aiello 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.
- Derived from this study: PubMed 19455069Reed 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.
- Link for patientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana SM Buist, Ph.D. principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing temporary discontinuation of hormone therapy for 1 month and temporary discontinuation of hormone therapy for 2 months in people with Breast Cancer, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mammogram Recall for Additional Imaging (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00117663, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.