Status:
COMPLETED
Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02
Lead Sponsor:
ETOP IBCSG Partners Foundation
Collaborating Sponsors:
National Cancer Institute (NCI)
Breast International Group
Conditions:
Breast Cancer
Osteoporosis
Eligibility:
FEMALE
18-120 years
Phase:
NA
Brief Summary
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 i...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 3 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2024
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00963417
Start Date
August 3 2009
End Date
October 23 2024
Last Update
July 14 2025
Active Locations (13)
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1
Royal Brisbane and Women's Hospital
Brisbane, Australia
2
Peter MacCallum Cancer Center
East Melbourne, Australia
3
Box Hill Hospital
Melbourne, Australia
4
Maroondah Hospital
Melbourne, Australia