Exemestane in Reducing Breast Density in Postmenopausal Women at Risk for Breast Cancer - Full Text View

Sponsored by:	National Cancer Institute of Canada
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00066586

Purpose

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.

Condition	Intervention
Breast Cancer	Drug: exemestane

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Exemestane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control
Official Title:	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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Change in breast density as measured by Boyd Scale at 1 year [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	August 2001

Detailed Description:

OBJECTIVES:

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 drug.

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066586

Locations

United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Rhode Island
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States, 02860
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L-4M1

Sponsors and Collaborators

National Cancer Institute of Canada

Investigators

Study Chair:

Paul E. Goss, MD, PhD

Massachusetts General Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000316328, CAN-NCIC-MAP2, PFIZER-971-ONC-0028-088
Study First Received:	August 6, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00066586 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Exemestane
Aromatase Inhibitors
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Breast Neoplasms
Enzyme Inhibitors
Exemestane
Aromatase Inhibitors
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009