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

Phase 3

Terminated

• Conditions: Breast Cancer; Osteoporosis
• Interventions: Procedure: spectroscopy

• Registration Number: NCT00899288
• Lead Sponsor: ETOP IBCSG Partners Foundation

Brief 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.

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-26
• Last Update Posted: 2012-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tamoxifen and no bone fracture	spectroscopy	Patients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have not had a bone fracture.
Letrozole and no bone fracture	spectroscopy	Patients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have not had a bone fracture.
Tamoxifen and bone fracture	spectroscopy	Patients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have had a bone fracture.
Letrozole and bone fracture	spectroscopy	Patients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have had a bone fracture.

Primary Outcome Measures

Name	Time	Method
Determination of bone health using fingernail assessments at baseline and 6 months	At baseline and 6 months after inclusion in the trial