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

Phase 3TerminatedNCT00899288

ETOP IBCSG Partners Foundation60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Breast Cancer Osteoporosis

Interventions

spectroscopyPROCEDURE

Nails will be chemically characterized using Raman spectroscopy.

Eligibility

Sex: FEMALEMin age: 30 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Determination of bone health using fingernail assessments at baseline and 6 months

Time frame: At baseline and 6 months after inclusion in the trial

Data from ClinicalTrials.gov

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