Breast CancerPhase 2NCT00238316
Letrozole in Preventing Breast Cancer in Postmenopausal Women Who Are at Increased Risk for Breast Cancer Due to High Breast Density
A Phase 2 study testing letrozole in people with Breast Cancer, run by NCIC Clinical Trials Group at 10 sites in 2 countries.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of letrozole may stop cancer from forming or coming back in postmenopausal women who are at increased risk for breast cancer due to high 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?
- letrozole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 5 Dec 2000to 10 Feb 2009
- Phase
- Phase 2
- 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:
- At increased risk for the development or recurrence of breast cancer, as defined by 1 of the following:
- Baseline mammogram indicating mammographic density occupying ≥ 25% (grade 4/6, 5/6, or 6/6) of the breast tissue
- No suspicion of breast cancer, unless subsequently ruled out
- Prior ductal carcinoma in situ (DCIS)
- Untreated disease OR > 6 months since completion of adjuvant endocrine therapy
- Receptor status of lesion is not required
- Prior invasive breast cancer
- Breast cancer must have been surgically removed at time of original diagnosis with no evidence of metastases
- No clinical evidence of breast cancer
- Acceptable quality dual-energy x-ray absorptiometry (DEXA) of the L2-L4 postero-anterior (PA) spine and hip performed within past 6 months
- Bone mass density T-score of either PA spine or hip must be ≥ 2.0 SD below the mean peak bone mass in young normal woman
- Stable chronic leukemia allowed
- Hormone receptor status:
- Hormone receptor-negative, -positive, or -equivocal tumor
PATIENT CHARACTERISTICS:
Age
- Postmenopausal
Sex
- Female
Menopausal status
- Postmenopausal, as defined by 1 of the following:
- Over 55 years of age with spontaneous cessation of menses for ≥ 1 year
- 55 years of age and under with spontaneous cessation of menses for ≤ 1 year, but amenorrheic (e.g., spontaneous or secondary to hysterectomy) AND follicle-stimulating hormone level > 34.4 IU/L
- Bilateral oophorectomy
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No recent unstable myocardial infarction
- No prior stroke
- No high blood pressure
- No other uncontrolled cardiovascular disease
Other
- Other prior malignancies without metastatic disease allowed
- Willing and able to complete quality of life questionnaires in either English or French
- No uncontrolled metabolic or endocrine disease
- No malabsorption syndrome
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
Chemotherapy
- No concurrent chemotherapy
Endocrine therapy
- See Disease Characteristics
- At least 3 months since prior and no concurrent hormone replacement therapy or raloxifene
- At least 6 months since prior tamoxifen
- No concurrent steroid therapy
- No concurrent selective estrogen-receptor modulators
- No other concurrent endocrine or hormonal therapy
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Canada8 sites
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, T2N 4N2
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Hamilton Osteoporosis Diagnostic Services
Hamilton, Ontario, L8N 1Y2
Hotel Dieu de Montreal
Montreal, Quebec, H2W 1T8
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, K1H 8L6
St. Catharines General Hospital at Niagara Health System
St. Catharines, Ontario, L2R 5K3
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
United States2 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115-6084
About this study
Official title: A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of letrozole may stop cancer from forming or coming back in postmenopausal women who are at increased risk for breast cancer due to high breast density.
PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women who are at increased risk for breast cancer due to high breast density.
Read the detailed description
OBJECTIVES:
Primary
- Determine the proportion of postmenopausal women who are at increased risk for the development or recurrence of breast cancer, based on high breast density (≥ grade 4), who achieve a decrease in breast density of ≥ 1 grade after treatment with letrozole for 1 year.
Secondary
- Determine whether a decrease in breast density grade is sustained at 1 year in patients treated with this drug.
- Correlate plasma estrogen profile (E1, E1S, E2) with breast density grade at baseline in these patients.
- Determine the percentage of patients with breast tissue hyperplasia and atypical hyperplasia, as assessed by histopathological examination of breast tissue biopsies, before and after treatment with this drug.
- Determine the changes in estrogen profile from baseline, at 1 year, and 1 year after cessation of this drug in these patients.
- Compare changes in predetermined specific parameters of safety at the end of 1 year of treatment with this drug with baseline evaluations of these patients.
- Determine whether modifications of these predetermined specific parameters of safety are sustained 1 year after cessation of treatment with this drug in these patients.
- Determine the general safety of 1 year of treatment with this drug in these patients.
- Compare the effects of this drug on menopause-specific quality of life of these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to breast density grade (4/6 vs 5/6 vs 6/6). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral letrozole once daily for 1 year in the absence of unacceptable toxicity.
- Arm II: Patients receive oral placebo once daily for 1 year in the absence of unacceptable toxicity.
Menopause-specific quality of life is assessed at baseline and then at 12 and 24 months.
After completion of study treatment, patients are followed at 6 months and 1 year.
PROJECTED ACCRUAL: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued for this study within 12 months.
- Conditions
- Breast Cancer
- Being tested
- letrozole, 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.
letrozoleDrug
2.5 mg PO daily for 1 year
PlaceboOther
2.5 mg PO daily for one 1 year
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Active comparator | Not described Receives: Drug: letrozole |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change of the BMD parameters from baseline BMD values
Measured: 7 years
Percentage change of bone biomarker measurements (serum bone alkaline phosphatase and urine N-telopeptide) from baseline values
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study start5 Dec 2000
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 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
- NCT00238316
- Sponsor's protocol ID
- MAP1
- Other IDs
- CAN-NCIC-MAP1, CDR0000445442
- Status last verified
- Mar 2020
- First submitted
- 12 Oct 2005
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cigler T, Tu D, Yaffe MJ, Findlay B, Verma S, Johnston D, Richardson H, Hu H, Qi S, Goss PE. A randomized, placebo-controlled trial (NCIC CTG MAP1) examining the effects of letrozole on mammographic breast density and other end organs in postmenopausal women. Breast Cancer Res Treat. 2010 Apr;120(2):427-35. doi: 10.1007/s10549-009-0662-0. Epub 2009 Dec 6.
PubMed 19967558
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 Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density
- ClinicalTrials.gov ID
- NCT00238316
- Acronym / sponsor ID
- MAP1
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 5 Dec 2000 (actual)
- Primary completion
- 16 Nov 2007 (actual)
- Study completion
- 10 Feb 2009 (actual)
- First posted
- 13 Oct 2005 (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: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of letrozole may stop cancer from forming or coming back in postmenopausal women who are at increased risk for breast cancer due to high breast density.
PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women who are at increased risk for breast cancer due to high breast density.
Detailed description
OBJECTIVES:
Primary
- Determine the proportion of postmenopausal women who are at increased risk for the development or recurrence of breast cancer, based on high breast density (≥ grade 4), who achieve a decrease in breast density of ≥ 1 grade after treatment with letrozole for 1 year.
Secondary
- Determine whether a decrease in breast density grade is sustained at 1 year in patients treated with this drug.
- Correlate plasma estrogen profile (E1, E1S, E2) with breast density grade at baseline in these patients.
- Determine the percentage of patients with breast tissue hyperplasia and atypical hyperplasia, as assessed by histopathological examination of breast tissue biopsies, before and after treatment with this drug.
- Determine the changes in estrogen profile from baseline, at 1 year, and 1 year after cessation of this drug in these patients.
- Compare changes in predetermined specific parameters of safety at the end of 1 year of treatment with this drug with baseline evaluations of these patients.
- Determine whether modifications of these predetermined specific parameters of safety are sustained 1 year after cessation of treatment with this drug in these patients.
- Determine the general safety of 1 year of treatment with this drug in these patients.
- Compare the effects of this drug on menopause-specific quality of life of these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to breast density grade (4/6 vs 5/6 vs 6/6). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral letrozole once daily for 1 year in the absence of unacceptable toxicity.
- Arm II: Patients receive oral placebo once daily for 1 year in the absence of unacceptable toxicity.
Menopause-specific quality of life is assessed at baseline and then at 12 and 24 months.
After completion of study treatment, patients are followed at 6 months and 1 year.
PROJECTED ACCRUAL: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued for this study within 12 months.
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 |
|---|---|---|
| Letrozole | Active comparator | Drug: letrozole |
| Placebo | Placebo comparator | Other: 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 |
|---|---|---|
| letrozole2.5 mg PO daily for 1 year | Drug | Letrozole |
| Placebo2.5 mg PO daily for one 1 year | Other | Placebo |
Primary outcome
Percentage change of the BMD parameters from baseline BMD values
Time frame: 7 years
Percentage change of bone biomarker measurements (serum bone alkaline phosphatase and urine N-telopeptide) from baseline values
Time frame: 7 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 19967558Cigler T, Tu D, Yaffe MJ, Findlay B, Verma S, Johnston D, Richardson H, Hu H, Qi S, Goss PE. A randomized, placebo-controlled trial (NCIC CTG MAP1) examining the effects of letrozole on mammographic breast density and other end organs in postmenopausal women. Breast Cancer Res Treat. 2010 Apr;120(2):427-35. doi: 10.1007/s10549-009-0662-0. Epub 2009 Dec 6.
- 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
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing letrozole in people with Breast Cancer, run by NCIC Clinical Trials Group at 10 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 10 sites in Canada, United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage change of the BMD parameters from baseline BMD values (time frame: 7 years). The study lists 2 primary outcomes in all. 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 NCT00238316, 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.