Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02 (TEXT-Bone)
July 9, 2025 updated by: ETOP IBCSG Partners Foundation
TEXT-Bone: A Substudy of the TEXT Trial to Evaluate Serial Bone Markers for Bone Remodeling, Serial Growth Factors, and Bone Mineral Density
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
119
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brisbane, Australia
- Royal Brisbane and Women's Hospital
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East Melbourne, Australia
- Peter MacCallum Cancer Center
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Melbourne, Australia
- Box Hill Hospital
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Melbourne, Australia
- Maroondah Hospital
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Perth, Australia
- Royal Perth Hospital
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Huy, Belgium
- Centre Hospitalier Regional de Huy
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Leuven, Belgium
- UZ Leuven
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Liège, Belgium
- C.H.U. Sart Tilman
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Liège, Belgium
- CHR Citadelle
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Verviers, Belgium
- C.H.P.L.T. de Verviers
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Bellinzona, Switzerland, CH-6500
- Oncology Institute of Southern Switzerland
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Bern, Switzerland
- Inselspital Bern
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St.Gallen, Switzerland
- Kantonsspital St.Gallen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 120 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
DISEASE CHARACTERISTICS:
- Patient must be eligible and enrolled in the TEXT-2 trial prior to enrolling in TEXT-Bone
- Serial bone marrow density (BMD) measurements must be taken within the same institution
- Hormone receptor positive
PATIENT CHARACTERISTICS:
- See Disease Characteristics
- Premenopausal
- No bone fracture in the past 6 months that, in the investigator's judgement, could be related to bone fragility
- No clinical or biochemical malabsorption syndrome, known vitamin D deficiency, active hyper- or hypoparathyroidism, or Paget's disease
- No uncontrolled thyroid disease, Cushing disease, or other pituitary diseases
- No other bone disease (including osteomalacia or osteogenesis imperfecta)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 6 months since prior and no concurrent bisphosphonate therapy (or other bone therapies such as PTH or strontium)
- At least 6 months since prior glucocorticoid (> 5 mg prednisone or equivalent) for > 1 month
- At least 12 months since prior anticonvulsants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Triptorelin plus tamoxifen
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.
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Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.
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).
|
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Experimental: Triptorelin plus exemestane
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.
|
Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase
Time Frame: 72 months after rnadomization to TEXT Study
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72 months after rnadomization to TEXT Study
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Serial serum levels of IGF-1 and IGFBP-3
Time Frame: 72 months after randomization to TEXT Study
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72 months after randomization to TEXT Study
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Serial BMD measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA)
Time Frame: 72 months after randomization to TEXT Study
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72 months after randomization to TEXT Study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Olivia Pagani, MD, Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 3, 2009
Primary Completion (Actual)
March 11, 2011
Study Completion (Actual)
October 23, 2024
Study Registration Dates
First Submitted
August 20, 2009
First Submitted That Met QC Criteria
August 20, 2009
First Posted (Estimated)
August 21, 2009
Study Record Updates
Last Update Posted (Actual)
July 14, 2025
Last Update Submitted That Met QC Criteria
July 9, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000637437
- IBCSG-25A-02
- BIG-25A-02
- NABCI-IBCSG-25A-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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