Fingernails in Evaluating Bone Health in Postmenopausal Women With Breast Cancer Undergoing Hormone Therapy on Clinical Trial IBCSG-1-98
NCT ID: NCT00899288
Last Updated: 2012-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
60 participants
INTERVENTIONAL
2005-04-30
2007-07-31
Brief Summary
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PURPOSE: This laboratory study is examining fingernails as a way of evaluating bone health in postmenopausal women with breast cancer undergoing hormone therapy on clinical trial IBCSG-1-98.
Detailed Description
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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 hormonal therapy on protocol IBCSG-1-98.
* Determine the efficacy of nail structure for evaluating bone fragility.
Secondary
* Compare fingernail assessments in patients who have had a bone fracture vs those who have not.
* Determine the natural variation in chemical (Raman spectroscopy) properties of 2 fingernails sourced at 1 appointment from the same donor.
* Evaluate the effect of further drug treatment (after 6 months) on the chemical properties of fingernails.
OUTLINE: This is a single-blind, multicenter, pilot study. Patients are stratified according to treatment on protocol IBCSG-1-98 (tamoxifen vs letrozole) and bone fracture (yes vs no).
Fingernail clippings are collected at baseline and 6 months later. Fingernail clippings are examined by Raman spectroscopy.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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tamoxifen and no bone fracture
Patients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have not had a bone fracture.
spectroscopy
Nails will be chemically characterized using Raman spectroscopy.
Letrozole and no bone fracture
Patients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have not had a bone fracture.
spectroscopy
Nails will be chemically characterized using Raman spectroscopy.
Tamoxifen and bone fracture
Patients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have had a bone fracture.
spectroscopy
Nails will be chemically characterized using Raman spectroscopy.
Letrozole and bone fracture
Patients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have had a bone fracture.
spectroscopy
Nails will be chemically characterized using Raman spectroscopy.
Interventions
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spectroscopy
Nails will be chemically characterized using Raman spectroscopy.
Eligibility Criteria
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Inclusion Criteria
* 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
30 Years
FEMALE
No
Sponsors
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ETOP IBCSG Partners Foundation
NETWORK
Responsible Party
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Principal Investigators
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Mark Towler, MD
Role: STUDY_CHAIR
Materials & Surface Science Institute at the University of Limerick
Other Identifiers
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IBCSG-18-98-FPS
Identifier Type: OTHER
Identifier Source: secondary_id
IBCSG-1-98-FPS
Identifier Type: OTHER
Identifier Source: secondary_id
EU-20625
Identifier Type: -
Identifier Source: secondary_id
CDR0000482403
Identifier Type: -
Identifier Source: org_study_id