Mammographic Breast DensityNCT00470561
Effect of Aspirin on Mammogram Density in Healthy Postmenopausal Women With a Moderate or High Level of Breast Density
A study testing Aspirin in people with Mammographic Breast Density, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Aspirin may be effective in reducing breast density in healthy postmenopausal women with a moderate or high level of breast density. PURPOSE: This randomized clinical trial is studying the effect of aspirin on mammogram density compared with a placebo in healthy postmenopausal women with a moderate or high… Read more about this study
- Who is it for?
- Ages 55 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammographic Breast Density
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Moderate or high density breast tissue on mammogram within the past 4 months
- Breast Imaging-Reporting and Data System (BIRAD) class 2-4 or digitized mammogram with ≥ 25% density
- Healthy without serious comorbidities
- Female
- Postmenopausal
- More than 3 weeks since prior and no other concurrent use (2 or more times per week) of acetylsalicylic acid (aspirin), ibuprofen, or other NSAIDs
Who cannot join
- history of breast cancer, including ductal carcinoma in situ or lobular carcinoma in situ
- history of illness for which NSAIDs are typically primary therapy (e.g., rheumatoid arthritis)
- Allergy to NSAIDs
- Anemia (hematocrit < 35%), abnormal bleeding tests, or bleeding disorders
- Gastrointestinal (GI) ulcer or history of GI bleeding
- Adverse reactions to aspirin acid or other NSAIDs
Show all 25Show fewer
- Renal disease
- Asthma
- Current or chronic liver disease
- History of hemorrhagic stroke or transient ischemic attack
- History of coronary artery disease, including any of the following:
- Myocardial infarction (MI)
- Angina
- Coronary artery disease documented on cardiac catheterization, exercise thallium, or exercise echocardiogram
- Strong family history of coronary artery disease (i.e., mother with MI before 55 years of age, father with MI before 45 years of age)
- Documented carotid artery disease
- Diabetes
- Uncontrolled hypertension
- No planned extensive weight loss in the next 6 months (≥ 10 pounds)
- More than 2 alcoholic drinks daily
- Mental illness or alcohol or drug abuse
- Prior angioplasty or coronary artery bypass grafting
- Prior breast implantation or reduction surgery
- Less than 6 months since prior hormones for menopause (including pills, patches, vaginal route), tamoxifen citrate, raloxifene, other hormonal therapy, or herbal or soy preparations
- Concurrent anticoagulation medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
About this study
Official title: The Effect of Aspirin on Mammogram Density (TEAM)
RATIONALE: Aspirin may be effective in reducing breast density in healthy postmenopausal women with a moderate or high level of breast density.
PURPOSE: This randomized clinical trial is studying the effect of aspirin on mammogram density compared with a placebo in healthy postmenopausal women with a moderate or high level of breast density.
Read the detailed description
OBJECTIVES:
Primary
- Compare the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density in healthy postmenopausal women with a moderate or high level of breast density.
Secondary
- Determine whether there is a differential response in mammogram density to aspirin treatments in individual homozygous wild-type, heterozygous, and homozygous variant for several UGT gene polymorphisms.
- Determine the effect of aspirin therapy on potential adverse events, including gastrointestinal symptoms and signs, bleeding events, blood pressure, and other major comorbidities and hospitalizations, as well as generalized symptoms, in these participants.
- Determine the effects of aspirin therapy on putative biomarkers of breast and ovarian cancer that are currently being validated as part of ongoing Fred Hutchinson Cancer Research Center Ovarian SPORE activities.
- Determine the effects of aspirin therapy on levels of serum estradiol, estrone and sex hormone binding globulin (SHBG) as measured by radioimmunoassay at baseline and 6 month timepoints
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Participants are randomized to 1 of 2 treatment arms.
- Arm I: Participants receive oral acetylsalicylic acid (aspirin) daily for 6 months.
- Arm II: Participants receive oral placebo daily for 6 months. In both arms, participants undergo a repeat mammogram at 6 months.
Blood and urine samples are collected at baseline and at 6 months. Single-nucleotide polymorphisms in the UGT genes and variable number of tandem repeat-type polymorphisms are genotyped.
PROJECTED ACCRUAL: A total of 144 participants will be accrued for this study.
- Conditions
- Mammographic Breast Density
- Being tested
- Aspirin, Placebo
- Keywords
- mammographic breast density aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Acetylsalicylic acid
Two 325 mg doses of aspirin per day for 6 months
PlaceboDrug
Also called Placebo, sugar pill
Two placebo pills per day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | Not described Receives: Drug: Aspirin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density
Measured: Baseline and end-of-study (6 month timepoint)
Secondary outcomes (4)
Differential response in mammogram density to aspirin treatments in individual homozygous wild-type, heterozygous, and homozygous variant for several UGT gene polymorphisms
Changes at baseline and 6 month timepoint in mammographic density; measurements of single numcleotide polymorphisms in specific genes from a single DNA samples
Measured: Baseline and end-of-study (6 month timepoint)
Adverse events
Measured: Collected over the course of tehestudy
Putative biomarkers of breast and ovarian cancer
Measured: Baseline and end-of-study (6 month timepoint)
Comparison of the effect of aspiring vs placebo on serum levels of estradiol, estrone and sex hormone binding globulin
Measured: Baseline and 6 month timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startNov 2005
- Primary completionJun 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mammographic Breast DensityStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Nicole Urban, ScD, Study chair, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470561
- Sponsor's protocol ID
- PHS 1908.00
- Other IDs
- FHCRC-PHS-1908.00, FHCRC-1908, CDR0000544639
- Status last verified
- Nov 2010
- First submitted
- 3 May 2007
- Last updated
- 15 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aspirin on Mammogram Density (TEAM)
- ClinicalTrials.gov ID
- NCT00470561
- Acronym / sponsor ID
- PHS 1908.00
- Conditions
- Mammographic Breast Density
- Keywords
- mammographic breast density aspirin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 7 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Aspirin may be effective in reducing breast density in healthy postmenopausal women with a moderate or high level of breast density.
PURPOSE: This randomized clinical trial is studying the effect of aspirin on mammogram density compared with a placebo in healthy postmenopausal women with a moderate or high level of breast density.
Detailed description
OBJECTIVES:
Primary
- Compare the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density in healthy postmenopausal women with a moderate or high level of breast density.
Secondary
- Determine whether there is a differential response in mammogram density to aspirin treatments in individual homozygous wild-type, heterozygous, and homozygous variant for several UGT gene polymorphisms.
- Determine the effect of aspirin therapy on potential adverse events, including gastrointestinal symptoms and signs, bleeding events, blood pressure, and other major comorbidities and hospitalizations, as well as generalized symptoms, in these participants.
- Determine the effects of aspirin therapy on putative biomarkers of breast and ovarian cancer that are currently being validated as part of ongoing Fred Hutchinson Cancer Research Center Ovarian SPORE activities.
- Determine the effects of aspirin therapy on levels of serum estradiol, estrone and sex hormone binding globulin (SHBG) as measured by radioimmunoassay at baseline and 6 month timepoints
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Participants are randomized to 1 of 2 treatment arms.
- Arm I: Participants receive oral acetylsalicylic acid (aspirin) daily for 6 months.
- Arm II: Participants receive oral placebo daily for 6 months. In both arms, participants undergo a repeat mammogram at 6 months.
Blood and urine samples are collected at baseline and at 6 months. Single-nucleotide polymorphisms in the UGT genes and variable number of tandem repeat-type polymorphisms are genotyped.
PROJECTED ACCRUAL: A total of 144 participants will be accrued for this study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: Aspirin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Moderate or high density breast tissue on mammogram within the past 4 months
- Healthy without serious comorbidities
- Female
- Postmenopausal
- More than 3 weeks since prior and no other concurrent use (2 or more times per week) of acetylsalicylic acid (aspirin), ibuprofen, or other NSAIDs
Key exclusion criteria (25 listed)
- history of breast cancer, including ductal carcinoma in situ or lobular carcinoma in situ
- history of illness for which NSAIDs are typically primary therapy (e.g., rheumatoid arthritis)
- Allergy to NSAIDs
- Anemia (hematocrit < 35%), abnormal bleeding tests, or bleeding disorders
- Gastrointestinal (GI) ulcer or history of GI bleeding
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 |
|---|---|---|
| AspirinAlso: Acetylsalicylic acidTwo 325 mg doses of aspirin per day for 6 months | Drug | Aspirin |
| PlaceboAlso: Placebo, sugar pillTwo placebo pills per day for 6 months | Drug | Placebo |
Primary outcome
Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density
Time frame: Baseline and end-of-study (6 month timepoint)
4 secondary outcomes
Differential response in mammogram density to aspirin treatments in individual homozygous wild-type, heterozygous, and homozygous variant for several UGT gene polymorphisms
Time frame: Baseline and end-of-study (6 month timepoint)
Adverse events
Time frame: Collected over the course of tehestudy
Putative biomarkers of breast and ovarian cancer
Time frame: Baseline and end-of-study (6 month timepoint)
Comparison of the effect of aspiring vs placebo on serum levels of estradiol, estrone and sex hormone binding globulin
Time frame: Baseline and 6 month timepoints
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2010.
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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.
Nicole Urban, ScD study chair
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin in people with Mammographic Breast Density, run by Fred Hutchinson Cancer Center 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 6 inclusion and 25 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 15 Nov 2010. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density (time frame: Baseline and end-of-study (6 month timepoint)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2010.