Clinical trial NCT00579826: Study of Breast Cancer Prevention by Letrozole in High Risk Women
Official title: Study of Breast Cancer Prevention by Letrozole in High Risk Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis
name: National Cancer Institute (NCI)
First posted: 2007-12-24
Enrollment: 55
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a multi-institution double-blind placebo-controlled trial whose main objective is to determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia or borderline atypia, and a minimum Ki-67 of \>1.5%.

The primary hypothesis is that proliferation and expression of other estrogen response genes will be favorably modulated by six months of letrozole relative to placebo without substantially increasing hot flashes or worsening overall quality of life.

Detailed description: Subsequent to the 6 month RPFNA for assessment of biomarkers, toxicity and quality of life assessments, all women may receive optional open-label letrozole for an additional 6 months, followed by a third RPFNA and biomarker

Eligibility criteria: Inclusion Criteria:

* Post-menopausal women at high risk for development of breast cancer
* stable dose of hormone replacement therapy
* have cytomorphologic evidence of hyperplasia +/- atypia and Ki-67 expression \>1.5% in benign breast epithelial cells acquired by RPFNA
* Serum level of 25-hydroxyvitamin D of at least 30 ng/ml prior to study entry
* Willing to have a repeat random periareolar fine needle aspiration (RPFNA) and mammogram at 6 months and 12 months (if participating in the open label portion of the study) following initiation of study drug

Exclusion Criteria:

* Prior history of osteoporosis or osteoporotic fracture.
* Prior history of invasive breast cancer or other invasive cancer within five years from date of study entry.
* Current and chronic use of cyclooxygenase-2 (COX-2) specific inhibitors or NSAIDs
* Receiving treatment for rheumatoid arthritis or fibromyalgia
* Current history of poorly controlled migraines or perimenopausal symptoms
* Currently receiving other investigational agents.
* Receipt of more than 6 months of an aromatase inhibitor (anastrozole, exemestane, letrozole, etc.) at any time in the past.

Primary outcomes:
measure: Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months
timeFrame: Baseline to 6 Months
Secondary outcomes:
measure: Assessment of Change in Morphology by the Masood Score.
timeFrame: Baseline to 6 Months
measure: Change in Mammographic Density From Baseline to 6 Months..
timeFrame: Baseline to 6 Months
Other outcomes:
measure: Change in Fibromyalgia Impact Questionnaire (FIQ) Score.
timeFrame: Baseline to 6 months
measure: Change in Brief Fatigue Inventory (BFI) Score.
timeFrame: baseline to 6 months
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Carol J Fabian, MD
role: PRINCIPAL_INVESTIGATOR
References: