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

Not Applicable

Completed

• Conditions: Osteoporosis; Breast Cancer

• Registration Number: NCT00963417
• Lead Sponsor: ETOP IBCSG Partners Foundation

Brief 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.

Study Timeline

• Study Start: 2009-08-03
• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Primary Completion: 2011-03-11
• Study Completion: 2024-10-23
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-09
• Last Update Posted: 2025-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 119

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serial serum levels of IGF-1 and IGFBP-3	72 months after randomization to TEXT Study
Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase	72 months after rnadomization to TEXT Study
Serial BMD measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA)	72 months after randomization to TEXT Study

Trial Locations

Locations (13)

Royal Brisbane and Women's Hospital; 🇦🇺 Brisbane, Australia

Peter MacCallum Cancer Center; 🇦🇺 East Melbourne, Australia

Box Hill Hospital; 🇦🇺 Melbourne, Australia

Maroondah Hospital; 🇦🇺 Melbourne, Australia

Royal Perth Hospital; 🇦🇺 Perth, Australia

Centre Hospitalier Regional de Huy; 🇧🇪 Huy, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

C.H.U. Sart Tilman; 🇧🇪 Liège, Belgium

CHR Citadelle; 🇧🇪 Liège, Belgium

C.H.P.L.T. de Verviers; 🇧🇪 Verviers, Belgium

Scroll for more (3 remaining)