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

ETOP IBCSG Partners Foundation119 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

119

Conditions

Breast Cancer Osteoporosis

Interventions

laboratory biomarker analysisOTHER

Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.

dual x-ray absorptiometryPROCEDURE

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).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (13)

Royal Brisbane and Women's Hospital

Brisbane, Australia

Peter MacCallum Cancer Center

East Melbourne, Australia

Box Hill Hospital

Melbourne, Australia

Outcomes

Primary Outcomes

Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase

Time frame: 72 months after rnadomization to TEXT Study

Serial serum levels of IGF-1 and IGFBP-3

Time frame: 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)

Time frame: 72 months after randomization to TEXT Study

Data from ClinicalTrials.gov

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