Clinical trial · Interventional
Letrozole in Preventing Breast Cancer in Postmenopausal Women
A Pilot Study of Aromatase Inhibitors for Women at Increased Risk of Breast Cancer Based on Estradiol Levels
NCT00090857CI-TRIAL-00032295WISEcompletedPhase 2Results postedClinicalTrials.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 therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Letrozole may be effective in preventing the development or recurrence of breast cancer in postmenopausal women who are at increased risk of developing breast cancer because of elevated estradiol levels. PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women with elevated estradiol levels.
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
- EXPERIMENTAL
- label
- Letrozole
- description
- Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
- interventionNames
- Drug: Letrozole
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
- interventionNames
- Other: Placebo
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * At increased risk for the development or recurrence of breast cancer, defined as an estradiol level ≥ 9 pg/mL * No evidence of suspicious or malignant disease, based on the following examinations: * Clinical bilateral breast examination within the past 6 months * Bilateral\* mammogram within 3 months before randomization OR within 30 days after randomization * Pelvic exam normal within the past 5 years * General physical exam within the past 6 months NOTE: \*Unilateral mammogram of the uninvolved breast for patients with prior invasive breast cancer or ductal carcinoma in situ (DCIS) * Bone density scan within 2 standard deviations from normal within the past 30 days * Bone density scan ≥ 2 standard deviations below normal allowed if approved by the study physician * At least 1 breast that has not been previously treated with radiotherapy or surgery (for patients with prior invasive breast cancer or DCIS) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 35 and over Sex * Female Menopausal status * Postmenopausal, defined by any of the following criteria: * At least 12 months without spontaneous menstrual bleeding * Prior hysterectomy and bilateral salpingo-oophorectomy * ≥ 55 years of age with a prior hysterectomy with or without oophorectomy * \< 55 years of age with a prior hysterectomy without oophorectomy OR the status of the ovaries is unknown AND follicle-stimulating hormone (FSH) level is in the postmenopausal range Performance status * Normal activity must not be restricted for a significant portion of the day Life expectancy * At least 10 years Hematopoietic * Complete blood count with differential normal * Prior benign neutropenia allowed provided the granulocyte count is ≥ 1,500/mm\^3 Hepatic * Bilirubin normal * Alkaline phosphatase normal * SGOT and SGPT normal Renal * Creatinine normal Cardiovascular * No uncontrolled cardiovascular disease Other * Not pregnant * No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No osteoporosis * No hyperlipidemia * No mental health status resulting in cognitive or emotional impairment that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * More than 30 days since prior AND no concurrent use of any of the following hormonal agents: * Estrogen or progesterone replacement therapy * Oral contraceptives * Raloxifene or other plasma estrogen receptor modulators (SERMs) * Androgens (e.g., danazol) * Luteinizing hormone-releasing hormone (LHRH) analogs (e.g., goserelin or leuprolide) * Prolactin inhibitors (e.g., bromocriptine) * Antiandrogens (e.g., cyproterone) * More than 60 days since prior AND no concurrent tamoxifen * No prior aromatase inhibitors (for patients with prior invasive breast cancer or DCIS) * No concurrent phytoestrogenic dietary supplements (e.g., soy, ginseng, or other natural products) * Dietary soy allowed Radiotherapy * See Disease Characteristics Surgery * See Disease Characteristics * No prior bilateral mastectomy Other * More than 60 days since prior treatment for invasive breast cancer or DCIS * More than 30 days since prior bisphosphonates or calcitonin * No prior or concurrent participation on a treatment study for invasive breast cancer or DCIS * No concurrent participation in any other cancer prevention study or osteoporosis prevention study involving pharmacologic agents * No concurrent calcitonin * No concurrent bisphosphonate therapy * Concurrent cholecalciferol (vitamin D) and calcium to augment bone mineral density allowed
References
Publications (0)
Data not yet available
No reference posted for this study.