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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:
ClinicalTrials.gov Identifier:
NCT00963417
First Posted: August 21, 2009
Last Update Posted: August 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Breast International Group
Information provided by (Responsible Party):
International Breast Cancer Study Group
  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
Breast Cancer Osteoporosis Other: laboratory biomarker analysis Procedure: dual x-ray absorptiometry

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]
  • 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 ]

Enrollment: 119
Study Start Date: July 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963417


Locations
Australia
Royal Brisbane and Women's Hospital
Brisbane, Australia
Peter MacCallum Cancer Center
East Melbourne, Australia
Box Hill Hospital
Melbourne, Australia
Maroondah Hospital
Melbourne, Australia
Royal Perth Hospital
Perth, Australia
Belgium
Centre Hospitalier Regional de Huy
Huy, Belgium
UZ Leuven
Leuven, Belgium
C.H.U. Sart Tilman
Liège, Belgium
CHR Citadelle
Liège, Belgium
C.H.P.L.T. de Verviers
Verviers, Belgium
Switzerland
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, CH-6500
Inselspital Bern
Bern, Switzerland
Kantonsspital St.Gallen
St.Gallen, Switzerland
Sponsors and Collaborators
International Breast Cancer Study Group
National Cancer Institute (NCI)
Breast International Group
Investigators
Study Chair: Olivia Pagani, MD Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
  More Information

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
First Submitted: August 20, 2009
First Posted: August 21, 2009
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Metabolic Diseases
Tamoxifen
Exemestane
Triptorelin Pamoate
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents