Fingernails in Evaluating Bone Health in Postmenopausal Women With Breast Cancer Undergoing Hormone Therapy on Clinical Trial IBCSG-1-98

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigating the Chemical Properties of Fingernails to Determine the Efficacy of Nail Structure for Evaluating Bone Fragility

Conditions
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Breast Cancer, Osteoporosis

Intervention / Treatment
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* Procedure: spectroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tamoxifen and no bone fracture<br>Patients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have not had a bone fracture. | Procedure: spectroscopy<br>* Nails will be chemically characterized using Raman spectroscopy.<br>|
| Experimental: Letrozole and no bone fracture<br>Patients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have not had a bone fracture. | Procedure: spectroscopy<br>* Nails will be chemically characterized using Raman spectroscopy.<br>|
| Experimental: Tamoxifen and bone fracture<br>Patients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have had a bone fracture. | Procedure: spectroscopy<br>* Nails will be chemically characterized using Raman spectroscopy.<br>|
| Experimental: Letrozole and bone fracture<br>Patients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have had a bone fracture. | Procedure: spectroscopy<br>* Nails will be chemically characterized using Raman spectroscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of bone health using fingernail assessments at baseline and 6 months |  | At baseline and 6 months after inclusion in the trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer