Breast CancerTEXT-BoneNCT00963417
Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02
A study testing laboratory biomarker analysis and dual x-ray absorptiometry in people with Breast Cancer and Osteoporosis, run by ETOP IBCSG Partners Foundation at 13 sites in 3 countries.
Trial summary
RATIONALE: Gathering information over time from bone density and laboratory tests of women with breast cancer treated with triptorelin and tamoxifen or exemestane may help the study of breast cancer in the future. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer, Osteoporosis
- What is being tested?
- laboratory biomarker analysis and dual x-ray absorptiometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 3 Aug 2009to 23 Oct 2024
- Phase
- Interventional
- 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 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Patient must be eligible and enrolled in the TEXT-2 trial prior to enrolling in TEXT-Bone
- Serial bone marrow density (BMD) measurements must be taken within the same institution
- Hormone receptor positive
PATIENT CHARACTERISTICS:
- See Disease Characteristics
- Premenopausal
- No bone fracture in the past 6 months that, in the investigator's judgement, could be related to bone fragility
- No clinical or biochemical malabsorption syndrome, known vitamin D deficiency, active hyper- or hypoparathyroidism, or Paget's disease
- No uncontrolled thyroid disease, Cushing disease, or other pituitary diseases
- No other bone disease (including osteomalacia or osteogenesis imperfecta)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 6 months since prior and no concurrent bisphosphonate therapy (or other bone therapies such as PTH or strontium)
- At least 6 months since prior glucocorticoid (> 5 mg prednisone or equivalent) for > 1 month
- At least 12 months since prior anticonvulsants
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Australia5 sites
Royal Brisbane and Women's Hospital
Brisbane
Peter MacCallum Cancer Center
East Melbourne
Box Hill Hospital
Melbourne
Maroondah Hospital
Melbourne
Royal Perth Hospital
Perth
Belgium5 sites
Centre Hospitalier Regional de Huy
Huy
UZ Leuven
Leuven
C.H.U. Sart Tilman
Liège
CHR Citadelle
Liège
C.H.P.L.T. de Verviers
Verviers
Switzerland3 sites
Oncology Institute of Southern Switzerland
Bellinzona, CH-6500
Inselspital Bern
Bern
Kantonsspital St.Gallen
Sankt Gallen
About this study
Official title: TEXT-Bone: A Substudy of the TEXT Trial to Evaluate Serial Bone Markers for Bone Remodeling, Serial Growth Factors, and Bone Mineral Density
RATIONALE: Gathering information over time from bone density and laboratory tests of women with breast cancer treated with triptorelin and tamoxifen or exemestane may help the study of breast cancer in the future.
PURPOSE: This clinical trial is studying changes in bone mineral density in women with breast cancer treated with triptorelin and tamoxifen or exemestane on protocol IBC SG-25-02 (TEXT).
Read the detailed description
OBJECTIVES:
- Evaluate changes in bone mineral density (BMD) among premenopausal women randomized in protocol IBC SG-25202 (TEXT-2) to receive either: A) triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years; or B) triptorelin (GnRH analogue) for 5 years plus the steroidal aromatase inhibitor exemestane for 5 years.
- Evaluate serial serum markers for bone remodeling (C-telopeptide, osteocalcin, bone-specific alkaline phosphatase) and investigate their correlation with BMD.
- Evaluate the relationship of genetic variants of CYP19A1, ERα, ERß, and IGF 1 with BMD.
- Evaluate serial serum growth factors (IGF-1 and IGFBP-3) and investigate whether their time course correlates with BMD.
- Explore the role of serum IGF-1 and IGFBP-3 as biomarkers of disease outcome (disease-free survival). (exploratory)
OUTLINE: Blood samples are collected at baseline and then periodically for 6 years. Serum markers of bone remodeling and serum growth factor levels are measured.
Bone mineral density in the L1-L4 (postero-anterior) region of the spine and femoral neck of the hip is measured by DEXA at baseline and then periodically for 6 years.
Any surplus serum is stored for use in unspecified future research.
- Conditions
- Breast Cancer, Osteoporosis
- Being tested
- laboratory biomarker analysis, dual x-ray absorptiometry
- Keywords
- osteoporosis, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, stage IA breast cancer, stage IB 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
Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.
dual x-ray absorptiometryProcedure or surgery
Serial bone mineral density measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA).
| Study group | Role | What they receive |
|---|---|---|
| Triptorelin plus tamoxifen | Active comparator | Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years. Receives: Other: laboratory biomarker analysis; Procedure: dual x-ray absorptiometry |
| Triptorelin plus exemestane | Experimental | Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus exemestane for 5 years. Receives: Other: laboratory biomarker analysis; Procedure: dual x-ray absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase
Measured: 72 months after rnadomization to TEXT Study
Serial serum levels of IGF-1 and IGFBP-3
Measured: 72 months after randomization to TEXT Study
Serial BMD measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA)
Measured: 72 months after randomization to TEXT Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study start3 Aug 2009
- Primary completion11 Mar 2011
- Study completion23 Oct 2024
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Breast International Group
- Responsible party
- Sponsor
- Investigators
- Olivia Pagani, MD, Study chair, Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963417
- Sponsor's protocol ID
- CDR0000637437
- Other IDs
- IBCSG-25A-02, BIG-25A-02, NABCI-IBCSG-25A-02
- Acronym
- TEXT-Bone
- Status last verified
- Jul 2025
- First submitted
- 20 Aug 2009
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEXT-Bone: A Substudy of the TEXT Trial to Evaluate Serial Bone Markers for Bone Remodeling, Serial Growth Factors, and Bone Mineral Density
- ClinicalTrials.gov ID
- NCT00963417
- Acronym / sponsor ID
- TEXT-Bone / CDR0000637437
- Conditions
- Breast Cancer, Osteoporosis
- Keywords
- osteoporosis, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- ETOP IBCSG Partners FoundationResearch network
- Collaborators
- National Cancer Institute (NCI), Breast International Group
- Study start
- 3 Aug 2009 (actual)
- Primary completion
- 11 Mar 2011 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 21 Aug 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: Gathering information over time from bone density and laboratory tests of women with breast cancer treated with triptorelin and tamoxifen or exemestane may help the study of breast cancer in the future.
PURPOSE: This clinical trial is studying changes in bone mineral density in women with breast cancer treated with triptorelin and tamoxifen or exemestane on protocol IBC SG-25-02 (TEXT).
Detailed description
OBJECTIVES:
- Evaluate changes in bone mineral density (BMD) among premenopausal women randomized in protocol IBC SG-25202 (TEXT-2) to receive either: A) triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years; or B) triptorelin (GnRH analogue) for 5 years plus the steroidal aromatase inhibitor exemestane for 5 years.
- Evaluate serial serum markers for bone remodeling (C-telopeptide, osteocalcin, bone-specific alkaline phosphatase) and investigate their correlation with BMD.
- Evaluate the relationship of genetic variants of CYP19A1, ERα, ERß, and IGF 1 with BMD.
- Evaluate serial serum growth factors (IGF-1 and IGFBP-3) and investigate whether their time course correlates with BMD.
- Explore the role of serum IGF-1 and IGFBP-3 as biomarkers of disease outcome (disease-free survival). (exploratory)
OUTLINE: Blood samples are collected at baseline and then periodically for 6 years. Serum markers of bone remodeling and serum growth factor levels are measured.
Bone mineral density in the L1-L4 (postero-anterior) region of the spine and femoral neck of the hip is measured by DEXA at baseline and then periodically for 6 years.
Any surplus serum is stored for use in unspecified future research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triptorelin plus tamoxifen | Active comparator | Other: laboratory biomarker analysis, Procedure: dual x-ray absorptiometryDetermination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years. |
| Triptorelin plus exemestane | Experimental | Other: laboratory biomarker analysis, Procedure: dual x-ray absorptiometryDetermination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus exemestane for 5 years. |
Who may qualify
- Ages
- 18 to 120 years
- 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 analysisSerial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization. | Other | Triptorelin plus exemestane, Triptorelin plus tamoxifen |
| dual x-ray absorptiometrySerial bone mineral density measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA). | Procedure or surgery | Triptorelin plus exemestane, Triptorelin plus tamoxifen |
Primary outcome
Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase
Time frame: 72 months after rnadomization to TEXT Study
Serial serum levels of IGF-1 and IGFBP-3
Time frame: 72 months after randomization to TEXT Study
Serial BMD measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA)
Time frame: 72 months after randomization to TEXT Study
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 14 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Olivia Pagani, MD study chair
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laboratory biomarker analysis and dual x-ray absorptiometry in people with Breast Cancer and Osteoporosis, run by ETOP IBCSG Partners Foundation at 13 sites in 3 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 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia, Belgium, Switzerland. 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.
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?
Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase (time frame: 72 months after rnadomization to TEXT Study). The study lists 3 primary outcomes in all. 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 14 Jul 2025.