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

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ClinicalTrials.gov Identifier: NCT00899288
Recruitment Status : Terminated (Insufficient accrual)
First Posted : May 12, 2009
Last Update Posted : July 27, 2012
Sponsor:
Information provided by (Responsible Party):
International Breast Cancer Study Group

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Osteoporosis Procedure: spectroscopy Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Investigating the Chemical Properties of Fingernails to Determine the Efficacy of Nail Structure for Evaluating Bone Fragility
Study Start Date : April 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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.
Procedure: spectroscopy
Nails will be chemically characterized using Raman 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.
Procedure: spectroscopy
Nails will be chemically characterized using Raman 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.
Procedure: spectroscopy
Nails will be chemically characterized using Raman 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.
Procedure: spectroscopy
Nails will be chemically characterized using Raman spectroscopy.



Primary Outcome Measures :
  1. Determination of bone health using fingernail assessments at baseline and 6 months [ Time Frame: At baseline and 6 months after inclusion in the trial ]


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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899288


Sponsors and Collaborators
International Breast Cancer Study Group
Investigators
Study Chair: Mark Towler, MD Materials & Surface Science Institute at the University of Limerick

Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT00899288     History of Changes
Other Study ID Numbers: CDR0000482403
IBCSG-18-98-FPS ( Other Identifier: International Breast Cancer Study Group )
IBCSG-1-98-FPS ( Other Identifier: International Breast Cancer Study Group )
EU-20625
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: July 27, 2012
Last Verified: July 2012

Keywords provided by International Breast Cancer Study Group:
osteoporosis
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Osteoporosis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Letrozole
Tamoxifen
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents