Effect of Aspirin on Mammogram Density in Healthy Postmenopausal Women With a Moderate or High Level of Breast Density

NCT00470561 | Completed DMC

• 4 other identifiers: PHS 1908.00FHCRC-PHS-1908.00FHCRC-1908CDR0000544639
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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 level of breast density.

Conditions

Mammographic Breast Density

Keywords

mammographic breast density aspirin

Outcome Measures

Primary Outcomes (1)

• Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density

  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

  Baseline and end-of-study (6 month timepoint)

• Adverse events

  Collected over the course of tehestudy

• Putative biomarkers of breast and ovarian cancer

  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

  Baseline and 6 month timepoints

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

Drug: Aspirin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Aspirin DRUG

Two 325 mg doses of aspirin per day for 6 months

Also known as: Acetylsalicylic acid

Aspirin

Placebo DRUG

Two placebo pills per day for 6 months

Also known as: Placebo, sugar pill

Placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Interventions

Aspirin; Sugars

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates

Study Officials

• Nicole Urban, ScD

  Fred Hutchinson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: November 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: July 1, 2007
• Last Updated: November 15, 2010

Record last verified: 2010-11

Locations

US (1)