None listed
Conditions
Interventions
COHORT 1 Type of group
This group of patients will correspond to those who have not yet completed the 2nd year of treatment of the main study. Patients in this group will continue with their BIG 1-98 protocol regimen (Letrozole PO 2.5 mg daily OR Tamoxifen PO 20 mg daily OR Letrozole PO 2.5 mg daily with Tamoxifen PO 20 mg daily).
They will undergo evaluations of bone densitometry, spine radiographs and serum biomarkers.
Group name:COHORT 3 Type of group
This group of patients will correspond to those who have completed the 3rd year but have not yet completed the 5th year of treatment of the main study. Patients in this group will continue with their BIG 1-98 protocol regimen (Letrozole PO 2.5 mg daily OR Tamoxifen PO 20 mg daily OR Letrozole PO 2.5 mg daily with Tamoxifen PO 20 mg daily). They will undergo evaluations of bone densitometry, spine radiographs and serum biomarkers.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients in the BIG 1-98 Trial without known, symptomatic bone disease. 2. Patients who have not yet completed 5 years of trial treatment and who have not had recurrence of breast cancer or a second primary cancer. 3. Written informed consent must be obtained and must be signed and dated by the patient and the investigator.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled thyroid and parathyroid disease, Cushing´s disease or other pituitary diseases. 2. Any known bone disease. 3. Malabsorption syndrome or clinically relevant vitamin D deficiency. 4. Use of raloxifene at any time. 5. Patients in whom the determination of bone density is impossible. 6. Record prior to the Bone Mineral Density sub-study of BIG 1-98.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:X-ray dual energy absorptiometry or bone densitometry of the lumbar spine (L2-L4) and hip. Measure:Bone mineral density. Timepoints:At the beginning of the substudy and annually until the end of the 6 years of treatment or until discontinuation of the same. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:X-ray of column (T4 - L4) in lateral projection. Measure:Bone mineral density in radiography. Timepoints:At the beginning of the substudy and annually until the end of the 6 years of treatment or until discontinuation of the same. ; Outcome name:Markers in serum: Osteocalcin, C-telopeptide, alkaline phosphatase. Measure:Bone remodeling. Timepoints:At the beginning of the substudy and annually until the end of the 6 years of treatment or until discontinuation of the same. | — |
Countries
Denmark, France, Peru, Switzerland
Outcome results
None listed