Breast Cancer Clinical Trial
Official title:
Investigating the Chemical Properties of Fingernails to Determine the Efficacy of Nail Structure for Evaluating Bone Fragility
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.
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.
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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