Exemestane in Reducing Breast Density in Postmenopausal Women at Risk for Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00066586
First received: August 6, 2003
Last updated: May 30, 2013
Last verified: September 2011
  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
Drug: Placebo

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

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Change in breast density as measured by Boyd Scale at 1 year [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: August 2001
Study Completion Date: February 2009
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exemestane Drug: exemestane
exemestane 25 mg once daily x 1 year
Placebo Comparator: Placebo Drug: Placebo
placebo once daily x 1 year

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
NCIC Clinical Trials Group
Investigators
Study Chair: Paul E. Goss, MD, PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00066586     History of Changes
Obsolete Identifiers: NCT00258648
Other Study ID Numbers: MAP2, CAN-NCIC-MAP2, PFIZER-971-ONC-0028-088, PDQ identifier
Study First Received: August 6, 2003
Last Updated: May 30, 2013
Health Authority: United States: Federal Government

Keywords provided by NCIC Clinical Trials Group:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014