Breast CancerNCT00066586
Exemestane in Reducing Breast Density in Postmenopausal Women at Risk for Breast Cancer
A study testing exemestane in people with Breast Cancer, run by NCIC Clinical Trials Group at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- exemestane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 1 Aug 2001to 10 Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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)
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States8 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, 43210-1240
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Canada4 sites
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L-4M1
Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- exemestane, Placebo
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exemestaneDrug
exemestane 25 mg once daily x 1 year
PlaceboDrug
placebo once daily x 1 year
| Study group | Role | What they receive |
|---|---|---|
| Exemestane | Active comparator | Not described Receives: Drug: exemestane |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breast density as measured by Boyd Scale at 1 year
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2003 (estimated)
- Study start1 Aug 2001
- Primary completion16 Nov 2007
- Study completion10 Feb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Paul E. Goss, MD, PhD, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066586
- Sponsor's protocol ID
- MAP2
- Other IDs
- CAN-NCIC-MAP2, PFIZER-971-ONC-0028-088, CDR0000316328
- Status last verified
- Mar 2020
- First submitted
- 6 Aug 2003
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21221773
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00066586
- Acronym / sponsor ID
- MAP2
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 1 Aug 2001 (actual)
- Primary completion
- 16 Nov 2007 (actual)
- Study completion
- 10 Feb 2009 (actual)
- First posted
- 7 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exemestane | Active comparator | Drug: exemestane |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- Up to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exemestaneexemestane 25 mg once daily x 1 year | Drug | Exemestane |
| Placeboplacebo once daily x 1 year | Drug | Placebo |
Primary outcome
Change in breast density as measured by Boyd Scale at 1 year
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Results publication: PubMed 21221773Cigler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul E. Goss, MD, PhD study chair
Massachusetts General Hospital
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exemestane in people with Breast Cancer, run by NCIC Clinical Trials Group at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in breast density as measured by Boyd Scale at 1 year (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00066586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.