Breast CancerPhase 3NCT00899288
Fingernails in Evaluating Bone Health in Postmenopausal Women With Breast Cancer Undergoing Hormone Therapy on Clinical Trial IBCSG-1-98
A Phase 3 study testing spectroscopy in people with Breast Cancer and Osteoporosis, run by ETOP IBCSG Partners Foundation.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Breast Cancer, Osteoporosis
- What is being tested?
- spectroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Jul 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Osteoporosis
- Being tested
- spectroscopy
- Keywords
- osteoporosis, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
- Medical subject headings
- Breast Neoplasms, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spectroscopyProcedure or surgery
Nails will be chemically characterized using Raman spectroscopy.
| Study group | Role | What they receive |
|---|---|---|
| tamoxifen and no bone fracture | Experimental | Patients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have not had a bone fracture. Receives: Procedure: spectroscopy |
| Letrozole and no bone fracture | Experimental | Patients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have not had a bone fracture. Receives: Procedure: spectroscopy |
| Tamoxifen and bone fracture | Experimental | Patients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have had a bone fracture. Receives: Procedure: spectroscopy |
| Letrozole and bone fracture | Experimental | Patients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have had a bone fracture. Receives: Procedure: spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of bone health using fingernail assessments at baseline and 6 months
Measured: At baseline and 6 months after inclusion in the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startApr 2005
- Primary completionJul 2007
- Study completionJul 2007
Why it stopped: Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Mark Towler, MD, Study chair, Materials & Surface Science Institute at the University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899288
- Sponsor's protocol ID
- CDR0000482403
- Other IDs
- IBCSG-18-98-FPS, IBCSG-1-98-FPS, EU-20625
- Status last verified
- Jul 2012
- First submitted
- 9 May 2009
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Chemical Properties of Fingernails to Determine the Efficacy of Nail Structure for Evaluating Bone Fragility
- ClinicalTrials.gov ID
- NCT00899288
- Acronym / sponsor ID
- CDR0000482403
- Conditions
- Breast Cancer, Osteoporosis
- Keywords
- osteoporosis, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient accrual
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ETOP IBCSG Partners FoundationResearch network
- Study start
- Apr 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tamoxifen and no bone fracture | Experimental | Procedure: spectroscopyPatients 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 | Experimental | Procedure: spectroscopyPatients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have not had a bone fracture. |
| Tamoxifen and bone fracture | Experimental | Procedure: spectroscopyPatients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have had a bone fracture. |
| Letrozole and bone fracture | Experimental | Procedure: spectroscopyPatients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have had a bone fracture. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spectroscopyNails will be chemically characterized using Raman spectroscopy. | Procedure or surgery | Letrozole and bone fracture, Letrozole and no bone fracture, Tamoxifen and bone fracture, tamoxifen and no bone fracture |
Primary outcome
Determination of bone health using fingernail assessments at baseline and 6 months
Time frame: At baseline and 6 months after inclusion in the trial
Results and safety
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Towler, MD study chair
Materials & Surface Science Institute at the University of Limerick
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing spectroscopy in people with Breast Cancer and Osteoporosis, run by ETOP IBCSG Partners Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2012.