Clinical trial · Interventional
Exemestane in Reducing Breast Density in Postmenopausal Women at Risk for Breast Cancer
A Randomized Study Of The Effect Of Exemestane (Aromasin) Versus Placebo On Breast Density In Postmenopausal Women At Increased Risk For Development Of Breast Cancer
NCT00066586CI-TRIAL-00044404completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. Exemestane may be effective in preventing the development of breast cancer by decreasing estrogen levels and reducing breast density. PURPOSE: Randomized clinical trial to study the effectiveness of exemestane in preventing the development of breast cancer by decreasing estrogen levels and reducing breast density in postmenopausal women who are at increased risk for breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exemestane | Drug | Exemestane | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Exemestane
- interventionNames
- Drug: exemestane
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Change in breast density as measured by Boyd Scale at 1 year
- timeFrame
- 6 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Radiologically confirmed density occupying at least 25% of the breast tissue on baseline mammogram\*
* Grade 2, 3, 4, 5, or 6 (Boyd classification)
* Participants with different grades between the 2 breasts should be classified according to a higher grade NOTE: \*Performed within 6 months before study entry
* Bone mineral density T-score of either posterior-anterior spine or hip (femoral neck) must be no greater than 2.0 standard deviations below the mean value of peak bone mass in young normal women as determined by DEXA scan within the past 6 months
* No concurrent breast cancer
* No prior invasive breast cancer or ductal carcinoma in situ
* No breast implants
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* Postmenopausal
Sex
* Female
Menopausal status
* Postmenopausal, defined as 1 of the following:
* Over 50 years of age with no spontaneous menses for at least 1 year
* 50 years of age and under with no menses (e.g., spontaneous or secondary to hysterectomy) within the past year AND a follicle-stimulating hormone level within institution postmenopausal range
* Bilateral oophorectomy
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No cardiovascular disease
* No history of myocardial infarction
* No history of stroke
* No uncontrolled high blood pressure
Other
* No uncontrolled metabolic or endocrine disease
* No malabsorption syndrome
* No known hypersensitivity to exemestane or its excipients
* No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior immunotherapy
* No concurrent immunotherapy
Chemotherapy
* No prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* More than 3 months since prior exogenous estrogen and/or progesterone/progestin therapy
* More than 6 months since prior selective estrogen-receptor modulators (e.g., tamoxifen, toremifene, or raloxifene)
* No concurrent selective estrogen-receptor modulators (e.g., tamoxifen, toremifene, or raloxifene)
* No concurrent steroids
* Vaginal estrogens allowed (e.g., Estring® or Vagifem®)
* No concurrent compounded creams
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* More than 4 weeks since prior investigational agents
* No other concurrent medications that would preclude study endpoints
* No concurrent over-the-counter products or supplements considered to have an estrogenic effect, including any of the following:
* Ginseng
* Ginkgo biloba
* Black cohosh
* Dong quai
* Fortified soy supplements (e.g., phytoestrogen preparations)References
Publications (1)
- RESULTCigler T, Richardson H, Yaffe MJ, Fabian CJ, Johnston D, Ingle JN, Nassif E, Brunner RL, Wood ME, Pater JL, Hu H, Qi S, Tu D, Goss PE. A randomized, placebo-controlled trial (NCIC CTG MAP.2) examining the effects of exemestane on mammographic breast density, bone density, markers of bone metabolism and serum lipid levels in postmenopausal women. Breast Cancer Res Treat. 2011 Apr;126(2):453-61. doi: 10.1007/s10549-010-1322-0. Epub 2011 Jan 9. PMID 21221773