Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02

NCT00963417 | Completed DMC

• 4 other identifiers: CDR0000637437IBCSG-25A-02BIG-25A-02NABCI-IBCSG-25A-02
• Study Type: interventional
• Target: 119
• Locations: 3 countries
• Sites: 13

Brief 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. 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).

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

Outcome Measures

Primary Outcomes (3)

• Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase

  72 months after rnadomization to TEXT Study

• Serial serum levels of IGF-1 and IGFBP-3

  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)

  72 months after randomization to TEXT Study

Study Arms (2)

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.

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.

Other: laboratory biomarker analysis; Procedure: dual x-ray absorptiometry

Interventions

laboratory biomarker analysis OTHER

Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.

Triptorelin plus exemestane; Triptorelin plus tamoxifen

dual x-ray absorptiometry PROCEDURE

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).

Triptorelin plus exemestane; Triptorelin plus tamoxifen

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ETOP IBCSG Partners Foundation: lead
• National Cancer Institute (NCI): collaborator
• Breast International Group: collaborator

Study Sites (13)

Royal Brisbane and Women's Hospital

Brisbane, Australia

Location

Peter MacCallum Cancer Center

East Melbourne, Australia

Location

Box Hill Hospital

Melbourne, Australia

Location

Maroondah Hospital

Melbourne, Australia

Location

Royal Perth Hospital

Perth, Australia

Location

Centre Hospitalier Regional de Huy

Huy, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

C.H.U. Sart Tilman

Liège, Belgium

Location

CHR Citadelle

Liège, Belgium

Location

C.H.P.L.T. de Verviers

Verviers, Belgium

Location

Oncology Institute of Southern Switzerland

Bellinzona, CH-6500, Switzerland

Location

Inselspital Bern

Bern, Switzerland

Location

Kantonsspital St.Gallen

Sankt Gallen, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms; Osteoporosis

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Olivia Pagani, MD

  Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 21, 2009
• Study Start: August 3, 2009
• Primary Completion: March 11, 2011
• Study Completion: October 23, 2024
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); BE (5); CH (3)