Breast CancerPhase 3NCT00369850
Bone Density and Bone Loss in Postmenopausal Women With Breast Cancer Receiving Treatment in Clinical Trial IBCSG-1-98
A Phase 3 study testing laboratory biomarker analysis, Dual energy X-ray absorptiometry (DEXA) and Spine X-ray in people with Breast Cancer and Osteoporosis, run by ETOP IBCSG Partners Foundation at 16 sites in 8 countries.
Trial summary
RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help measure bone loss in women receiving treatment for breast cancer. The test results may help doctors plan better treatment. 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?
- laboratory biomarker analysis, Dual energy X-ray absorptiometry (DEXA) and Spine X-ray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 16 sitesin 8 countries
- Study dates
- May 2004to Jan 2012
- 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:
- Diagnosis of breast cancer
- Resected disease
- Enrolled on protocol IBCSG-1-98
- Receiving adjuvant endocrine therapy comprising 1 of the following regimens:
- Letrozole
- Tamoxifen
- Letrozole after 2 years of tamoxifen
- Tamoxifen after 2 years of letrozole
- Not yet completed 5 years of treatment
- No breast cancer recurrence or second primary cancer
- No known, symptomatic bone disease, including osteomalacia or osteogenesis imperfecta
- No prior registration to protocol IBCSG-1-98 Bone Mineral Density substudy
- Hormone receptor status:
- Estrogen receptor-positive 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
- No patients for whom the bone density determination is impossible
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 1 year since prior and no concurrent anticonvulsants
- More than 6 weeks since prior and no concurrent corticosteroids (at doses > the equivalent of 5 mg/day 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 prior treatment, either investigational or not, for the prevention of osteoporosis (excluding calcium or cholecalciferol [vitamin D])
- No concurrent raloxifene
- Concurrent therapeutic intervention for osteoporosis comprising bisphosphonates allowed
- Concurrent warfarin allowed provided it is given for ≤ 4 weeks
Trial locations and contacts
16 sites in 8 countries.
16 sites in 8 countries
Switzerland6 sites
Kantonspital Aarau
Aarau, CH-5001
Inselspital Bern
Bern, CH-3010
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
Ospedale Beata Vergine
Mendrisio, CH-6850
Kantonsspital - St. Gallen
Sankt Gallen, CH-9007
Regionalspital
Thun, 3600
Italy3 sites
Centro di Riferimento Oncologico - Aviano
Aviano, 33081
Ospedali Riuniti di Bergamo
Bergamo, 24100
European Institute of Oncology
Milan, 20141
Australia2 sites
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Institute of Oncology at Prince of Wales Hospital
Randwick, New South Wales, 2031
About this study
Official title: Investigating Bone Density and Bone Loss Without Baseline Information
RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help measure bone loss in women receiving treatment for breast cancer. The test results may help doctors plan better treatment.
PURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women with breast cancer receiving treatment in clinical trial IBCSG-1-98.
Read the detailed description
OBJECTIVES:
- Compare the effects on bone mineral density (BMD) in the L2-L4 (posterio-anterior) region of the spine and hip by assessing bone density in postmenopausal women with breast cancer receiving treatment on protocol IBCSG-1-98.
- Compare the incidence of radiological gross changes and fractures identified from spine x-rays (T4-L4) in these patients (in groups 1 and 2).
- Use longitudinal BMD measurements to estimate a linear rate of bone loss based on mixed effect models.
- Identify serum markers for bone loss to determine how they correlate with osteoporosis, microfractures, clinical fractures, and breast cancer-related bone events.
OUTLINE: This is a multicenter study and a substudy of protocol IBCSG-1-98. Patients are assigned to 1 of 3 groups according to the length of treatment they have undergone on protocol IBCSG-1-98.
- Group 1 (prior to or at the end of the second year of treatment on protocol IBCSG-1-98): Patients undergo bone mineral density (BMD) testing of the L2-L4 spine and hip at baseline and years 1, 2, 3, and 4 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 1, 3, and 4 from baseline.
- Group 2 (after 2 years but before the end of the third year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1, 2, and 3 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 2 and 3 from baseline.
- Group 3 (after 3 years but before the end of the fifth year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1 and 2 from baseline (for patients in 4th year of treatment) or year 1 from baseline (for patients in 5th year of treatment).
Patients undergo blood collection at baseline and periodically during study for biomarker correlative study.
PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study.
- Conditions
- Breast Cancer, Osteoporosis
- Being tested
- laboratory biomarker analysis, Dual energy X-ray absorptiometry (DEXA), Spine X-ray
- 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.
laboratory biomarker analysisOther
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Dual energy X-ray absorptiometry (DEXA)Procedure or surgery
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Spine X-rayProcedure or surgery
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen for 5 years | Experimental | Patients treated with tamoxifen for 5 years after randomisation. Receives: Other: laboratory biomarker analysis; Procedure: Dual energy X-ray absorptiometry (DEXA); Procedure: Spine X-ray |
| Letrozole for 5 years | Experimental | Patients treated with letrozole for 5 years after randomisation. Receives: Other: laboratory biomarker analysis; Procedure: Dual energy X-ray absorptiometry (DEXA); Procedure: Spine X-ray |
| Tamoxifen 2 years plus letrozole 3 years | Experimental | Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years. Receives: Other: laboratory biomarker analysis; Procedure: Dual energy X-ray absorptiometry (DEXA); Procedure: Spine X-ray |
| Letrozole 2 years plus tamoxifen 3 years | Experimental | Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years. Receives: Other: laboratory biomarker analysis; Procedure: Dual energy X-ray absorptiometry (DEXA); Procedure: Spine X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative percent change of bone mineral density (BMD) form baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98
Measured: 5 years after randomisation to BIG 1-98
Recovery of BMD at 1 year after the completion of treatment on protocol IBCSG-1-98
Measured: 6 years after randomisation to BIG 1-98
Proportion of patients with BMD below the absolute threshold value for osteoporosis
Measured: 5 years after randomisation to BIG 1-98
Relative percent change in markers of bone resorption from baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98
Measured: 5 years after randomisation to BIG 1-98
Recovery of the markers of bone resorption at 1 year after the completion of treatment on protocol IBCSG-1-98
Measured: 6 years after randomisation to BIG 1-98
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startMay 2004
- Primary completionMay 2008
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Stefan Aebi, MD, Study chair, Insel Gruppe AG, University Hospital BernAndrea Decensi, MD, Study chair, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369850
- Sponsor's protocol ID
- CDR0000482381
- Other IDs
- IBCSG-18-98-BS, EU-20623, IBCSG-1-98-BS, NOVARTIS-2026703019
- Status last verified
- Jul 2012
- First submitted
- 24 Aug 2006
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Decensi A, Sun Z, Guerrieri-Gonzaga A, Thurlimann B, McIntosh C, Tondini C, Monnier A, Campone M, Debled M, Schonenberger A, Zaman K, Johansson H, Price KN, Gelber RD, Goldhirsch A, Coates AS, Aebi S. Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences. Breast Cancer Res Treat. 2014 Apr;144(2):321-9. doi: 10.1007/s10549-014-2849-2. Epub 2014 Feb 1.
PubMed 24487691
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 Bone Density and Bone Loss Without Baseline Information
- ClinicalTrials.gov ID
- NCT00369850
- Acronym / sponsor ID
- CDR0000482381
- 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
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- ETOP IBCSG Partners FoundationResearch network
- Study start
- May 2004
- Primary completion
- May 2008 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 29 Aug 2006 (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: Diagnostic procedures, such as bone mineral density testing and x-ray, help measure bone loss in women receiving treatment for breast cancer. The test results may help doctors plan better treatment.
PURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women with breast cancer receiving treatment in clinical trial IBCSG-1-98.
Detailed description
OBJECTIVES:
- Compare the effects on bone mineral density (BMD) in the L2-L4 (posterio-anterior) region of the spine and hip by assessing bone density in postmenopausal women with breast cancer receiving treatment on protocol IBCSG-1-98.
- Compare the incidence of radiological gross changes and fractures identified from spine x-rays (T4-L4) in these patients (in groups 1 and 2).
- Use longitudinal BMD measurements to estimate a linear rate of bone loss based on mixed effect models.
- Identify serum markers for bone loss to determine how they correlate with osteoporosis, microfractures, clinical fractures, and breast cancer-related bone events.
OUTLINE: This is a multicenter study and a substudy of protocol IBCSG-1-98. Patients are assigned to 1 of 3 groups according to the length of treatment they have undergone on protocol IBCSG-1-98.
- Group 1 (prior to or at the end of the second year of treatment on protocol IBCSG-1-98): Patients undergo bone mineral density (BMD) testing of the L2-L4 spine and hip at baseline and years 1, 2, 3, and 4 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 1, 3, and 4 from baseline.
- Group 2 (after 2 years but before the end of the third year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1, 2, and 3 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 2 and 3 from baseline.
- Group 3 (after 3 years but before the end of the fifth year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1 and 2 from baseline (for patients in 4th year of treatment) or year 1 from baseline (for patients in 5th year of treatment).
Patients undergo blood collection at baseline and periodically during study for biomarker correlative study.
PROJECTED ACCRUAL: A total of 660 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 for 5 years | Experimental | Other: laboratory biomarker analysis, Procedure: Dual energy X-ray absorptiometry (DEXA), Procedure: Spine X-rayPatients treated with tamoxifen for 5 years after randomisation. |
| Letrozole for 5 years | Experimental | Other: laboratory biomarker analysis, Procedure: Dual energy X-ray absorptiometry (DEXA), Procedure: Spine X-rayPatients treated with letrozole for 5 years after randomisation. |
| Tamoxifen 2 years plus letrozole 3 years | Experimental | Other: laboratory biomarker analysis, Procedure: Dual energy X-ray absorptiometry (DEXA), Procedure: Spine X-rayPatients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years. |
| Letrozole 2 years plus tamoxifen 3 years | Experimental | Other: laboratory biomarker analysis, Procedure: Dual energy X-ray absorptiometry (DEXA), Procedure: Spine X-rayPatients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years. |
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 |
|---|---|---|
| laboratory biomarker analysisBiomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum. | Other | Letrozole 2 years plus tamoxifen 3 years, Letrozole for 5 years, Tamoxifen 2 years plus letrozole 3 years, Tamoxifen for 5 years |
| Dual energy X-ray absorptiometry (DEXA)Mone mineral density measurements of L2-L4 and hip will be performed using DEXA. | Procedure or surgery | Letrozole 2 years plus tamoxifen 3 years, Letrozole for 5 years, Tamoxifen 2 years plus letrozole 3 years, Tamoxifen for 5 years |
| Spine X-rayThoracic and lumbar X-ray (T4-L4, lateral projection) will be performed. | Procedure or surgery | Letrozole 2 years plus tamoxifen 3 years, Letrozole for 5 years, Tamoxifen 2 years plus letrozole 3 years, Tamoxifen for 5 years |
Primary outcome
Relative percent change of bone mineral density (BMD) form baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98
Time frame: 5 years after randomisation to BIG 1-98
Recovery of BMD at 1 year after the completion of treatment on protocol IBCSG-1-98
Time frame: 6 years after randomisation to BIG 1-98
Proportion of patients with BMD below the absolute threshold value for osteoporosis
Time frame: 5 years after randomisation to BIG 1-98
Relative percent change in markers of bone resorption from baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98
Time frame: 5 years after randomisation to BIG 1-98
Recovery of the markers of bone resorption at 1 year after the completion of treatment on protocol IBCSG-1-98
Time frame: 6 years after randomisation to BIG 1-98
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
- Derived from this study: PubMed 24487691Decensi A, Sun Z, Guerrieri-Gonzaga A, Thurlimann B, McIntosh C, Tondini C, Monnier A, Campone M, Debled M, Schonenberger A, Zaman K, Johansson H, Price KN, Gelber RD, Goldhirsch A, Coates AS, Aebi S. Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences. Breast Cancer Res Treat. 2014 Apr;144(2):321-9. doi: 10.1007/s10549-014-2849-2. Epub 2014 Feb 1.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Stefan Aebi, MD study chair
Insel Gruppe AG, University Hospital Bern
Andrea Decensi, MD study chair
European Institute of Oncology
16 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing laboratory biomarker analysis, Dual energy X-ray absorptiometry (DEXA) and Spine X-ray in people with Breast Cancer and Osteoporosis, run by ETOP IBCSG Partners Foundation at 16 sites in 8 countries.
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: finished, 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.
Where is the study taking place?
The record lists 16 sites in Switzerland, Italy, Australia, France, New Zealand and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relative percent change of bone mineral density (BMD) form baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98 (time frame: 5 years after randomisation to BIG 1-98). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00369850, which also lists 1 linked publication.
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.