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

Not Applicable

Active, not recruiting

• Conditions: Osteoporosis; Breast Cancer
• Interventions: Other: laboratory biomarker analysis; Procedure: dual x-ray absorptiometry

• 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
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-05-31
• Study Completion: 2025-12

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triptorelin plus tamoxifen	dual x-ray absorptiometry	Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years.
Triptorelin plus tamoxifen	laboratory biomarker analysis	Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years.
Triptorelin plus exemestane	laboratory biomarker analysis	Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus exemestane for 5 years.
Triptorelin plus exemestane	dual x-ray absorptiometry	Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus exemestane for 5 years.

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)

UZ Leuven; 🇧🇪 Leuven, Belgium

Centre Hospitalier Regional de Huy; 🇧🇪 Huy, Belgium

Peter MacCallum Cancer Center; 🇦🇺 East Melbourne, Australia

Box Hill Hospital; 🇦🇺 Melbourne, Australia

Maroondah Hospital; 🇦🇺 Melbourne, Australia

Royal Perth Hospital; 🇦🇺 Perth, Australia

CHR Citadelle; 🇧🇪 Liège, Belgium

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

Inselspital Bern; 🇨🇭 Bern, Switzerland

Kantonsspital St.Gallen; 🇨🇭 St.Gallen, Switzerland

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

Oncology Institute of Southern Switzerland; 🇨🇭 Bellinzona, Switzerland

C.H.U. Sart Tilman; 🇧🇪 Liège, Belgium