Clinical trial · Interventional
Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer
A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density
- 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)
The purpose of this study to see what happens to breast density in healthy postmenopausal women after treatment with letrozole in one year, compared with treatment with placebo for one year. Other goals of the study include determining if there is a connection between estrogen level and breast density for women in the study and collecting information about the quality of life of those taking part in the study.
Conditions
Conditions (2)
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 |
| Post-Menopausal | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the proportion of women with breast density of > grade 4 who have a decrease in breast density of at least one grade after treatment with letrozole for one year.
Secondary outcomes (6)
- measure
- To determine if the decrease in breast density grade is sustained one year after cessation of therapy
- measure
- to determine if there is a correlation between plasma estrogen profile and breast density at baseline
- measure
- to determine the percentage of subjects with breast tissue hyperplasia and atypical hyperplasia before and after therapy
- measure
- to assess change in estrogen profile from baseline and at 1 year and 1 year after cessation of therapy
- measure
- to assess the general safety of the utilization of letrozole in healthy post-menopausal women for one year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal status defined as: women \>55 years of age-no spontaneous menses for at least 12 months; in women \< 55 years-no spontaneous menses within the past 12 months and with an FSH level \>34.4 IU/I; bilateral oophorectomy * If subject had prior invasive breast cancer it must have been surgically removed at the time of orginal diagnosis with no evidence of metastases and the primary tumor may be receptive negative, positive or equivocal * Baseline mammogram (within 6 months) indicating mammographic density occupying \>25% (grade 4/5, 5/6 or 6/6) of the breast tissue * Baseline breast examination demonstrating no clinical evidence of breast cancer * Acceptable quality DEXA of the L2-L4 postero-anterior (PA) spine and hup must be performed 6 months of randomization * Subject is willing and able to complete the quality of life questionnaire in either English or French Exclusion Criteria: * Mammogram suspicious for breast cancer (unless subsequently ruled out) * Patient's with prior malignancies are eligible unless they have metastatic disease * Uncontrolled metabolic or endocrine disease, cardiovascular disease or malabsorption syndrome * Current chemotherapy or immunotherapy * Hormone replacement therapy or Evista (raloxifene) discontinued less than three months before baseline mammogram * Tamoxifen therapy discontinued less than six months prior to randomization
References
Publications (0)
Data not yet available