Clinical trial · Interventional
Letrozole in Preventing Breast Cancer in Postmenopausal Women Who Are at Increased Risk for Breast Cancer Due to High Breast Density
A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density
NCT00238316CI-TRIAL-00044419completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| letrozole | Drug | Letrozole | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Letrozole
- interventionNames
- Drug: letrozole
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Other: Placebo
Primary outcomes (2)
- measure
- Percentage change of the BMD parameters from baseline BMD values
- timeFrame
- 7 years
- measure
- Percentage change of bone biomarker measurements (serum bone alkaline phosphatase and urine N-telopeptide) from baseline values
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 120 Years
Show eligibility criteria text
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 CharacteristicsReferences
Publications (1)
- RESULTCigler 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. PMID 19967558