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
IBCSG 25-02 / BIG 3-02: Tamoxifen and Exemestane Trial (TEXT) - A phase III trial evaluating the role of exemestane plus Gonadotropin-releasing hormone (GnRH)analogue as adjuvant therapy for premenopausal women with endocrine responsive breast cancer. The TEXT-Bone Substudy evaluates serial bone markers for bone remodelling, serial growth factors, and bone mineral density for patients randomized to TEXT-2.
Breast Cancer Trials
200 participants
Nov 1, 2009
Interventional
Conditions
Summary
The purpose of this research is to compare the effect of the treatments (Tamoxifen and Exemestane) used in the main trial (TEXT-2) on bones. This will provide researchers and doctors with information as to whether these drugs are safe in terms of bone health and if there are increased or decreased risks of osteoporosis with the treatments. Approximately 200 patient's will be enrolled in this sub-study worldwide. Every patient will be in the sub-study for an average period of six years. However, participation in the study could be shorter depending on the response to the treatment on the main study.
Eligibility
Inclusion Criteria1
- 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 Criteria8
- 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.
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Interventions
Prior to registration in the TEXT-Bone Substudy, patients must be randomised to the TEXT-2 parent trial (Protocol Amendment 2 of IBCSG 25-02 / BIG 3-02 Tamoxifen and Exemestane Trial - TEXT). TEXT-2 re-starts recruitment. The TEXT trial will evaluate the worth of ovarian function suppression (achieved by long-term use of Gonadotropin-releasing hormone (GnRH) analogue (Triptorelin) 3.75mg by intramuscular injection every 28 days for 5 years from randomisation) plus exemestane 25mg orally daily until 5 years from date of randomisation (Exemestane should start after adjuvant chemotherapy has been completed or approximately six to eight weeks after the initiation of Gonadotropin-releasing hormone (GnRH) analogue (Triptorelin) whichever is later) compared with Gonadotropin-releasing hormone (GnRH) analogue (Triptorelin) 3.75mg by intramuscular injection every 28 days for 5 years from randomisation plus tamoxifen 20mg orally daily until 5 years from date of randomisation (Tamoxifen should start after adjuvant chemotherapy has been completed or approximatley six weeks to eight weeks after the initiation of Gonadotropin-releasing hormone (GnRH) analogue (Triptorelin), whichever is later) for premenopausal women with steroid hormone receptor positive early invasive breast cancer. Patients may either receive no chemotherapy or commence chemotherapy at the same time that Gonadotropin-releasing hormone (GnRH)analogue is initiated. Women will be randomised in a 2-arm design to receive one of the following: a. Ovarian Function Suppression (triptorelin) + Tamoxifen b. Ovarian Function Suppression (triptorelin) + Exemestane All treatment will be for 5 years.
Locations(1)
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ACTRN12609000532202