NCT00066586

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2001

Longer than P75 for not_applicable breast-cancer

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2009

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

6.3 years

First QC Date

August 6, 2003

Last Update Submit

March 31, 2020

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

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

    6 years

Study Arms (2)

Exemestane

ACTIVE COMPARATOR
Drug: exemestane

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

exemestaneDRUG

exemestane 25 mg once daily x 1 year

Exemestane
PlaceboDRUG

placebo once daily x 1 year

Placebo

Eligibility Criteria

AgeUp to 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (12)

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L-4M1, Canada

Location

Related Publications (1)

  • Cigler 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: 21221773RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Paul E. Goss, MD, PhD

    Massachusetts General Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2003

First Posted

August 7, 2003

Study Start

August 1, 2001

Primary Completion

November 16, 2007

Study Completion

February 10, 2009

Last Updated

April 2, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(8)CA(4)