Clinical trial · Interventional
LY353381 in Preventing Breast Cancer in Women With Hyperplasia
A Phase II Clinical Trial of a Selective Estrogen Receptor Modulator (LY353381*HCl) in High Risk Women With Fine Needle Aspiration Cytologic Evidence of Hyperplasia
NCT00005879CI-TRIAL-00027831completedPhase 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. The use of LY353381 may be an effective way to prevent the development of breast cancer in women who have hyperplasia. PURPOSE: Randomized phase II trial to study the effectiveness of LY353381 in preventing breast cancer in women who have hyperplasia.
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 |
|---|---|---|---|
| arzoxifene | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Arzoxifene
- description
- LY353381, 20 mg daily
- interventionNames
- Drug: arzoxifene
Primary outcomes (2)
- measure
- Change in Masood Score
- timeFrame
- Baseline to 6 months
- description
- Change in the semi-quantitative score assigned by the designated cytopathologist. Range 6-24. Score represents increasing abnormality (i.e., worse appearance) Sum composite of 6 cytomorphological features, each scored as 1-4.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Current random fine needle breast aspiration (FNA) evidence of 1 of the following: * Hyperplasia with atypia * Hyperplasia without atypia but with a 10-year modified Gail risk of at least 4% * Hyperplasia without atypia but with a BRCAPRO risk of at least 25% * Hyperplasia without atypia but with a known mutation in BRCA1 or BRCA2 * Hyperplasia without atypia but with a history of contralateral ductal carcinoma in situ or invasive breast cancer * FNA must have been taken during days 1-14 of the menstrual cycle for premenopausal women * Classified as ACR class I-III on mammogram with stepwedge within past 6 months If intact uterus and/or ovaries, must have color doppler transvaginal pelvic sonogram within past 6 months showing endometrial thickening no greater than 13 mm premenopausal or no greater than 8 mm postmenopausal * No ovarian cysts felt to be possibly or probably non-physiologic that have not resolved to gynecologist's satisfaction on repeat sonogram * Must agree to have or have had genetic counseling and genetic testing performed for BRCA1 and BRCA2 * No active cancer (e.g., detectable disease) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Any Performance status: * Not specified Life expectancy: * At least 12 months Hematopoietic: * Hemoglobin greater than 10 g/dL * Granulocyte count greater than 1,000/mm\^3 * No deficiencies in protein C, protein S, or antithrombin III * No activated protein C resistance Hepatic: * Albumin greater than 3.0 g/dL * Bilirubin less than 1.5 mg/dL * AST less than 100 U/L * Alkaline phosphatase less than 200 U/L Renal: * Creatinine less than 1.5 mg/dL Cardiovascular: * No history of deep venous thrombosis not related to trauma or pregnancy * No severe coronary artery disease * No history of prior stroke Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study * No other active cancer * No retinal vein thrombosis * No concurrent severe poorly controlled migraine * No factor V Leiden mutation carrier PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 12 months since prior immunotherapy Chemotherapy: * At least 3 months between completion of prior KUMC phase II difluoromethylornithine (DFMO) study and baseline aspiration * At least 12 months since prior chemotherapy Endocrine therapy: * Must not have started or stopped hormone replacement therapy or oral contraceptives within 6 months of baseline aspiration * Must continue all hormone replacement therapy and/or oral contraceptives that were being taken at time of baseline aspiration * At least 12 months since prior tamoxifen, raloxifene, or other antihormonal therapy Radiotherapy: * At least 3 months since prior radiotherapy Surgery: * At least 6 months between prior oophorectomy and baseline aspiration Other: * At least 2 weeks since the start of other new medication that would be ingested for 1 or more months
References
Publications (0)
Data not yet available
No reference posted for this study.