Tamoxifen and Exemestane Trial Bone Substudy - A substudy to Amendment 2 of the IBCSG 25-02 / BIG 3-02: Tamoxifen and Exemestane Trial (ACTRN12605000418673) hereby referred to as TEXT-2, which evaluates the effects of exemestane plus Gonadotropin-releasing hormone (GnRH) analogue as adjuvant therapy for premenopausal women with endocrine responsive breast cancer

Phase 3

Active, not recruiting

Conditions: Effects of adjuvant endocrine therapies on bone mineral density in pre-menopausal breast cancer patients.
Cancer - Breast

Registration Number: ACTRN12609000532202

Lead Sponsor: Breast Cancer Trials

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: Female

Target Recruitment: 118

Inclusion Criteria

Patients must be eligible and enrolled in the TEXT-2 trial prior to enrollment in TEXT-Bone. Patients must have given informed consent for the TEXT-Bone substudy. the informed consent form must be signed and dated by the patient and her clinician.

Exclusion Criteria

Patients who have received bisphosphonate therapy (or other bone therapies such as Parathyroid hormone (PTH) or Strontium) within the previous 6 months or who are currently receiving therapy. Concomitant calcium and Vitamin D supplements are permitted and strongly recommended.
Patients who in the previous 6 months have had a bone fracture which in the investigator's judgement could be related to bone fragility.
Patients who have used a glucocorticoid (>5mg prednidone or equivalent) for more than one month in the previous 6 months.
Patients taking anticonvulsants within the previous 12 months.
Patients with clinical or biochemical malabsorption syndrome, or known vitamin D deficiency, active hyper- or hypoparathyroidism, or Paget's disease.
Uncontrolled thyroid disease, Cushing's disease or other pituitary diseases.
Any other bone disease (including osteomalacia, osteogenesis imperfecta).
Patients for whom serial BMD measuerment within the same institution is ompossible.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate changes in bone mineral density (BMD) among pre-menopausal women randomized to 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.[ Bone Mineral Density (BMD) measured by Dual energy X-ray absorptiometry (DEXA) in L1-L4 (postero-anterior, PA) region of the spine and hip is required as baseline, 12, 36, 60, and 72 month visits.]

Secondary Outcome Measures

Name	Time	Method
Evaluate serial serum markers for bone remodelling (C-telopeptide, osteocalcin, bone-specific alkaline phosphatase) and investigate their correlation with BMD.[ Morning fasting blood samples for serum are required as baseline, 12, 36, 60, and 72 month visits.];Evaluate serial serum growth factors Insulin-like growth factor (IGF-1) and Insulin-like growth factor binding protein-3 (IGFBP-3) and investigate whether their time course correlates with bone mineral density (BMD).[ Morning fasting blood samples for serum are required as baseline, 12, 36, 60, and 72 month visits.];Explore the role of serum Insulin-like growth factor (IGF-1) and Insulin-like growth factor binding protein-3 (IGFBP-3) FBP-3 as biomarkers of disease outcome (disease-free survival).[ Morning fasting blood samples for serum are required as baseline, 12, 36, 60, and 72 month visits.]