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

This study has been terminated.
(Insufficient accrual)
Sponsor:
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00899288
First received: May 9, 2009
Last updated: July 26, 2012
Last verified: July 2012
History of Changes

May 9, 2009
July 26, 2012
April 2005
July 2007   (final data collection date for primary outcome measure)
Determination of bone health using fingernail assessments at baseline and 6 months [ Time Frame: At baseline and 6 months after inclusion in the trial ] [ Designated as safety issue: No ]
Determination of bone health using fingernail assessments at baseline and 6 months [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00899288 on ClinicalTrials.gov Archive Site
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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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Breast Cancer
  • Osteoporosis
Procedure: spectroscopy
Nails will be chemically characterized using Raman spectroscopy.
  • Experimental: tamoxifen and no bone fracture
    Patients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have not had a bone fracture.
    Intervention: Procedure: spectroscopy
  • Experimental: Letrozole and no bone fracture
    Patients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have not had a bone fracture.
    Intervention: Procedure: spectroscopy
  • Experimental: Tamoxifen and bone fracture
    Patients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have had a bone fracture.
    Intervention: Procedure: spectroscopy
  • Experimental: Letrozole and bone fracture
    Patients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have had a bone fracture.
    Intervention: Procedure: spectroscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
July 2007
July 2007   (final data collection date for primary outcome measure)

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
Female
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00899288
CDR0000482403, IBCSG-18-98-FPS, IBCSG-1-98-FPS, EU-20625
Yes
International Breast Cancer Study Group
International Breast Cancer Study Group
Not Provided
Study Chair: Mark Towler, MD Materials & Surface Science Institute at the University of Limerick
International Breast Cancer Study Group
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP