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:
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: November 1, 2013
Last verified: November 2013
  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: January 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 1, 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 July 23, 2014