Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02 (TEXT-Bone)
This study is ongoing, but not recruiting participants.
Sponsor:
International Breast Cancer Study Group
Collaborators:
Breast International Group
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00963417
First received: August 20, 2009
Last updated: April 3, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Osteoporosis |
Other: laboratory biomarker analysis Procedure: dual x-ray absorptiometry |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by International Breast Cancer Study Group:
Primary Outcome Measures:
- Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase [ Time Frame: 72 months after rnadomization to TEXT Study ] [ Designated as safety issue: No ]
- Serial serum levels of IGF-1 and IGFBP-3 [ Time Frame: 72 months after randomization to TEXT Study ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Triptorelin plus tamoxifen
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.
|
Other: laboratory biomarker analysis
Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.
Procedure: dual x-ray absorptiometry
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).
|
|
Experimental: Triptorelin plus exemestane
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.
|
Other: laboratory biomarker analysis
Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.
Procedure: dual x-ray absorptiometry
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).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963417
Locations
| Canada, Alberta | |
| Tom Baker Cancer Centre - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Switzerland | |
| Oncology Institute of Southern Switzerland | |
| Bellinzona, Switzerland, CH-6500 | |
Sponsors and Collaborators
International Breast Cancer Study Group
Breast International Group
Investigators
| Study Chair: | Olivia Pagani, MD | Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni |
More Information
Additional Information:
No publications provided
| Responsible Party: | International Breast Cancer Study Group |
| ClinicalTrials.gov Identifier: | NCT00963417 History of Changes |
| Other Study ID Numbers: | CDR0000637437, IBCSG-25A-02, BIG-25A-02, NABCI-IBCSG-25A-02 |
| Study First Received: | August 20, 2009 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Federal Government Belgium: Federal Agency for Medicinal Products and Health Products Switzerland: Swissmedic Italy: The Italian Medicines Agency |
Keywords provided by International Breast Cancer Study Group:
|
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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Osteoporosis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Tamoxifen Triptorelin Exemestane Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 16, 2013