Breast Cancer
Conditions
Keywords
Breast Density
Brief summary
The primary objective of this study is to determine if sulindac at a dose of 150 mg twice a day for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control.
Interventions
DRUGSulindac Pill
Randomized participants will receive either 150 mg oral sulindac twice daily.
DRUGPlacebo
placebo pills twice daily
Sponsors
Alison Stopeck
Medical University of South Carolina
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≤70 years 2. Subject must be postmenopausal. 3. Must have at least one healthy normal appearing breast (no prior diagnosis of invasive cancer, radiation or prosthetics). Prior biopsies are acceptable. 4. Must have dense breasts 5. Must be at elevated risk for developing breast cancer by abnormal pathological findings, family history, or genetic predisposition 6. A negative fecal occult blood test 7. Normal organ function 8. Hormonal therapy with aromatase inhibitors is allowed
Exclusion criteria
1. Daily aspirin or other daily anti inflammatory use. 2. Known intolerance to anti inflammatory. 3. Use of any selective estrogen receptor modulator therapy (e.g., tamoxifen, raloxifene) within past 12 months 4. Gastrointestinal, bleeding or coagulation, cardiovascular disorders. 5. Diabetes requiring insulin therapy. 6. Current regular smoker. 7. History of claustrophobia or inability to undergo imaging in a closed magnetic resonance imaging. 8. Cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses that would preclude MRI. 9. Uncontrolled hypertension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percent Breast Density by MRI Between Treatment Arms | 12 months | The primary objective of this study is to determine if sulindac at a dose of 150 mg BID for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control. The dependent variable is the relative change in percent breast density. Percent breast density is the estimated percentage of breast volume that appears dense versus fatty on the MRI, and relative change is calculated as the difference between the follow-up and baseline values divided by the baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percent Breast Density by MRI Between Treatment Arms | 6 months | The secondary objective of this study is to determine if sulindac at a dose of 150 mg BID for 6 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control. The dependent variable is the relative change in percent breast density. Percent breast density is the estimated percentage of breast volume that appears dense versus fatty on the MRI, and relative change is calculated as the difference between the follow-up and baseline values divided by the baseline value. |
| Changes in Percent Breast Density by MRI Within and Between Treatment Arms, Stratified by Use of Aromatase Inhibitors | 12 months | The secondary objective is to determine if sulindac at a dose of 150 mg BID for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control, with analyses stratified by aromatase inhibitor (AI) use. Results are reported separately for participants on AI therapy and those not on AI therapy. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlison S Stopeck, MD
Stony Brook University
PRINCIPAL_INVESTIGATORPatricia A Thompson-Carino, PhD
University of Arizona
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60 Year |
| Baseline breast density | 18.5 percentage |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Not available | 0 Participants |
| Race/Ethnicity, Customized White | 27 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 27 / 31 | 22 / 30 |
| serious Total, serious adverse events | 1 / 31 | 1 / 30 |
Outcome results
None listed