NCT00963417

Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02

TEXT-Bone: A Substudy of the TEXT Trial to Evaluate Serial Bone Markers for Bone Remodeling, Serial Growth Factors, and Bone Mineral Density

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: ETOP IBCSG Partners Foundation · Network
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Gathering information over time from bone density and laboratory tests of women with breast cancer treated with triptorelin and tamoxifen or exemestane may help the study of breast cancer in the future. PURPOSE: This clinical trial is studying changes in bone mineral density in women with breast cancer treated with triptorelin and tamoxifen or exemestane on protocol IBC SG-25-02 (TEXT).

Detailed description

OBJECTIVES: * Evaluate changes in bone mineral density (BMD) among premenopausal women randomized in protocol IBC SG-25202 (TEXT-2) to receive either: A) triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years; or B) triptorelin (GnRH analogue) for 5 years plus the steroidal aromatase inhibitor exemestane for 5 years. * Evaluate serial serum markers for bone remodeling (C-telopeptide, osteocalcin, bone-specific alkaline phosphatase) and investigate their correlation with BMD. * Evaluate the relationship of genetic variants of CYP19A1, ERα, ERß, and IGF 1 with BMD. * Evaluate serial serum growth factors (IGF-1 and IGFBP-3) and investigate whether their time course correlates with BMD. * Explore the role of serum IGF-1 and IGFBP-3 as biomarkers of disease outcome (disease-free survival). (exploratory) OUTLINE: Blood samples are collected at baseline and then periodically for 6 years. Serum markers of bone remodeling and serum growth factor levels are measured. Bone mineral density in the L1-L4 (postero-anterior) region of the spine and femoral neck of the hip is measured by DEXA at baseline and then periodically for 6 years. Any surplus serum is stored for use in unspecified future research.

Conditions

• Breast Cancer
• Osteoporosis

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis	Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.
PROCEDURE	dual x-ray absorptiometry	Serial bone mineral density measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA).

Timeline

• Start date: 2009-08-03
• Primary completion: 2011-03-11
• Completion: 2024-10-23
• First posted: 2009-08-21
• Last updated: 2025-07-14

Locations

13 sites across 3 countries: Australia, Belgium, Switzerland