Status:
TERMINATED
Fingernails in Evaluating Bone Health in Postmenopausal Women With Breast Cancer Undergoing Hormone Therapy on Clinical Trial IBCSG-1-98
Lead Sponsor:
ETOP IBCSG Partners Foundation
Conditions:
Breast Cancer
Osteoporosis
Eligibility:
FEMALE
30+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Studying samples of fingernails in the laboratory from patients with breast cancer may help in evaluating bone health in postmenopausal women undergoing hormone therapy for breast cancer. ...
Detailed Description
OBJECTIVES: Primary * Compare the effects of tamoxifen vs letrozole on the chemical properties of fingernails by Raman spectroscopy in postmenopausal women with breast cancer undergoing adjuvant hor...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Enrolled on protocol IBCSG-1-98
- Currently receiving (i.e., have not yet completed) 5 years of treatment with tamoxifen or letrozole and expected to receive ≥ 6 months of additional treatment on protocol IBCSG-1-98
- No recurrent breast cancer or second primary cancer
- No known bone disease (including osteomalacia or osteogenesis imperfecta)
- Hormone receptor status
- Estrogen and/or progesterone receptor positive tumor
- PATIENT CHARACTERISTICS:
- Female
- Postmenopausal
- No uncontrolled thyroid or parathyroid disease, Cushing's disease, or other pituitary diseases
- No malabsorption syndrome or clinically relevant vitamin D deficiency
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 1 year since prior and no concurrent anticonvulsants
- More than 6 months since prior and no concurrent corticosteroids at doses \> the equivalent of 5 mg/day of prednisone for \> 2 weeks total
- No prior or concurrent sodium fluoride at daily doses ≥ 5 mg/day for \> 1 month
- More than 12 months since prior and no concurrent anabolic steroids
- More than 6 months since any prior drug for the prevention of osteoporosis (excluding calcium or cholecalciferol \[vitamin D\])
- Concurrent warfarin allowed provided duration of treatment is no more than 4 weeks
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00899288
Start Date
April 1 2005
End Date
July 1 2007
Last Update
July 27 2012
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