A Study to Evaluate the Effect of Letrozole and Tamoxifen on Bone and Lipids in Postmenopausal Women With Breast Cancer
- Conditions
- Hormone Sensitive Resected Primary Breast Cancer in Postmenopausal Women
- Interventions
- Registration Number
- NCT00171704
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Estrogen is known to be a regulator of bone and lipid metabolism. Letrozole is a potent inhibitor of estrogen synthesis.
This study evaluated the effects of letrozole and tamoxifen on bone and lipid metabolism in postmenopausal women with resected, receptor positive early breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 263
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Letrozole Letrozole 2.5 mg once daily (q.d.)orally for 5 years Tam-Let Letrozole 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years. Tam-Let Tamoxifen 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4) Baseline, 24 months Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine Baseline, 60 months Lumbar spine (L2-L4)BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.
Median Percent Change From Baseline of Serum Markers of Bone Turnover Baseline, 60 months Bone turnover markers (fasting serum procollagen-I extension peptide \[P1NP\], C-telopeptide \[CTX\], skeletal bone-specific alkaline phosphatase \[BSAP, N-telopeptide \[NTX\]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. The analysis of bone markers was based on analysis of variance of the regression slopes calculated for each individual patient and each bone marker over time. In the following summary, only the median treatment group percent change from baseline (and range) at 5 years is presented for each bone marker.
Percentage Change From Baseline in Serum Lipids at 5 Years Baseline, 60 months Serum lipid profile (fasting serum cholesterol \[total, HDL and calculated LDL\], triglycerides, and lipoprotein \[a\]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. The analysis of serum lipids was on the treatment group median percent change from baseline (and range) at 5 years.
Number of Participants With Clinically Relevant Changes From Baseline in Cholesterol Baseline, 60 months Serum lipid profile (fasting serum cholesterol \[total, HDL and calculated LDL\], triglycerides, and lipoprotein \[a\]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. Numbers are not additive, as patients could be included in multiple rows.
Time to Disease Recurrence or Death 60 months Disease-free survival was defined as the interval between randomization and earliest confirmed event of loco-regional recurrence, distant metastases, invasive contralateral breast cancer, or death from any cause.
Time to Overall Survival Events 60 Months Overall survival was measured from date of randomization to date of death.
Percent Change From Baseline of Bone Mineral Density (BMD) of Total Hip Baseline, 60 months Total hip BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. All DXA scans were evaluated by a central reader.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧Sheffield, United Kingdom