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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

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Breast Cancer

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Trial Information

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


- Determine the efficacy of exemestane in decreasing breast density at least 1 grade in
postmenopausal women with increased radiological breast density at increased risk for
breast cancer.

- Determine whether the decrease in breast density is sustained 1 year after the
cessation of this drug in these participants.

- Correlate the grade of breast density with bone density at baseline and at 1 year in
participants treated with this drug.

- Determine the overall safety of this drug, in terms of bone and lipid metabolism and
toxicity, in these participants.

- Determine the menopause-specific quality of life of participants treated with this

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
Participants are stratified according to baseline mammographic density grade (2 vs 3 vs 4 vs
5 vs 6). Participants are randomized to 1 of 2 treatment arms.

- Arm I: Participants receive oral exemestane once daily for 1 year.

- Arm II: Participants receive oral placebo once daily for 1 year. In both arms,
treatment continues in the absence of disease or unacceptable toxicity.

Quality of life is assessed at baseline and then at 3, 6, 9, 12, 18, and 24 months.

Participants are followed at 18 and 24 months.

PROJECTED ACCRUAL: A total of 120 participants (60 per treatment arm) will be accrued for
this study.

Inclusion Criteria


- 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



- Postmenopausal


- 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


- Not specified


- Not specified


- Not specified


- No cardiovascular disease

- No history of myocardial infarction

- No history of stroke

- No uncontrolled high blood pressure


- 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


Biologic therapy

- No prior immunotherapy

- No concurrent immunotherapy


- No prior chemotherapy

- No concurrent chemotherapy

Endocrine therapy

- More than 3 months since prior exogenous estrogen and/or progesterone/progestin

- 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

- No concurrent steroids

- Vaginal estrogens allowed (e.g., EstringĀ® or VagifemĀ®)

- No concurrent compounded creams


- Not specified


- Not specified


- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Change in breast density as measured by Boyd Scale at 1 year

Outcome Time Frame:

6 years

Safety Issue:


Principal Investigator

Paul E. Goss, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital


United States: Federal Government

Study ID:




Start Date:

August 2001

Completion Date:

February 2009

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms



Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus, Ohio  43210-1240
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115
Memorial Hospital of Rhode Island Pawtucket, Rhode Island  02860