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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
exemestane
Placebo
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Mayo Clinic - Jacksonville
  • Massachusetts General Hospital Cancer Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Mayo Clinic Cancer Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
  • Memorial Hospital of Rhode Island
  • Margaret and Charles Juravinski Cancer Centre
  • Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
  • Princess Margaret Hospital
  • Centre Hospitalier de l'Universite de Montreal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Exemestane

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 6, 2003
Last Updated
March 31, 2020
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00066586
Brief Title
Exemestane in Reducing Breast Density in Postmenopausal Women at Risk for Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2001 (Actual)
Primary Completion Date
November 16, 2007 (Actual)
Study Completion Date
February 10, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exemestane
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
exemestane
Intervention Description
exemestane 25 mg once daily x 1 year
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo once daily x 1 year
Primary Outcome Measure Information:
Title
Change in breast density as measured by Boyd Scale at 1 year
Time Frame
6 years

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul E. Goss, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Memorial Hospital of Rhode Island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L-4M1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21221773
Citation
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.
Results Reference
result

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

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