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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Osteoporosis

Intervention / Treatment
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* Other: laboratory biomarker analysis
* Procedure: dual x-ray absorptiometry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triptorelin plus tamoxifen<br>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. | Other: laboratory biomarker analysis<br>* Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.<br>Procedure: dual x-ray absorptiometry<br>* 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).<br>|
| Experimental: Triptorelin plus exemestane<br>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. | Other: laboratory biomarker analysis<br>* Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.<br>Procedure: dual x-ray absorptiometry<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase |  | 72 months after rnadomization to TEXT Study | 
| Serial serum levels of IGF-1 and IGFBP-3 |  | 72 months after randomization 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer