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

TERMINATEDPHASE3

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

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

NCT00899288•ETOP IBCSG Partners Foundation

View on ClinicalTrials.gov

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. 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

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.

Eligibility

Age

30 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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
+10 more criteria

Key Dates

Start Date

April 1, 2005

Primary Completion Date

July 1, 2007

Completion Date

July 1, 2007

Last Updated

July 27, 2012

Enrollment

ESTIMATED participants

Conditions

Breast CancerOsteoporosis

Interventions

spectroscopy

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer