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

July 26, 2012 updated by: ETOP IBCSG Partners Foundation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Determination of bone health using fingernail assessments at baseline and 6 months
Time Frame: At baseline and 6 months after inclusion in the trial
At baseline and 6 months after inclusion in the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ETOP IBCSG Partners Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mark Towler, MD, Materials & Surface Science Institute at the University of Limerick

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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