LY353381 in Preventing Breast Cancer in Women With Hyperplasia

NCT00005879 | Completed Phase 2 Results

• 4 other identifiers: KUMC-HSC-7264-97CDR0000067918NCI-P00-0146U01CA077165
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 2

Brief Summary

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

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (2)

• Change in Masood Score

  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.

  Baseline to 6 months

• Number of Participants With Improvement From Baseline in Cytomorphologic Abnormality at 6 Months

  Change (improvement) in categorical descriptor of cytologic abnormality as assigned by the primary cytopathologist. Categories include: normal (non-proliferative), epithelial hyperplasia, epithelial hyperplasia with atypia.

  Baseline to 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Arzoxifene

EXPERIMENTAL

LY353381, 20 mg daily

Drug: arzoxifene

Interventions

arzoxifene DRUG

one tablet daily

Also known as: LY353381

Arzoxifene

Placebo DRUG

matched tablet dialy

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160-7820, United States

Location

U.S. Oncology Research, Inc.

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

LY 353381

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Bruce F. Kimler, Ph.D.
• Organization: University of Kansas Medical Center

bkimler@kumc.edu

913-588-4523

Study Officials

• Carol J. Fabian, MD

  University of Kansas

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Breast Cancer Prevention Unit

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: January 27, 2003
• Study Start: August 1, 2000
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: May 30, 2017
• Results First Posted: May 30, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)