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).
Who can participate
Age range
18 Years – 120 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase
Timeframe: 72 months after rnadomization to TEXT Study
2
Serial serum levels of IGF-1 and IGFBP-3
Timeframe: 72 months after randomization to TEXT Study
3
Serial BMD measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA)
Timeframe: 72 months after randomization to TEXT Study