Bone Density and Bone Loss in Postmenopausal Women With Breast Cancer Receiving Treatment in Clinical Trial IBCSG-1-98

Phase 3

Completed

• Conditions: Breast Cancer; Osteoporosis
• Interventions: Other: laboratory biomarker analysis; Procedure: Dual energy X-ray absorptiometry (DEXA); Procedure: Spine X-ray

• Registration Number: NCT00369850
• Lead Sponsor: ETOP IBCSG Partners Foundation

Brief Summary

RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help measure bone loss in women receiving treatment for breast cancer. The test results may help doctors plan better treatment.

PURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women with breast cancer receiving treatment in clinical trial IBCSG-1-98.

Detailed Description

OBJECTIVES:

* Compare the effects on bone mineral density (BMD) in the L2-L4 (posterio-anterior) region of the spine and hip by assessing bone density in postmenopausal women with breast cancer receiving treatment on protocol IBCSG-1-98.

* Compare the incidence of radiological gross changes and fractures identified from spine x-rays (T4-L4) in these patients (in groups 1 and 2).

* Use longitudinal BMD measurements to estimate a linear rate of bone loss based on mixed effect models.

* Identify serum markers for bone loss to determine how they correlate with osteoporosis, microfractures, clinical fractures, and breast cancer-related bone events.

OUTLINE: This is a multicenter study and a substudy of protocol IBCSG-1-98. Patients are assigned to 1 of 3 groups according to the length of treatment they have undergone on protocol IBCSG-1-98.

* Group 1 (prior to or at the end of the second year of treatment on protocol IBCSG-1-98): Patients undergo bone mineral density (BMD) testing of the L2-L4 spine and hip at baseline and years 1, 2, 3, and 4 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 1, 3, and 4 from baseline.

* Group 2 (after 2 years but before the end of the third year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1, 2, and 3 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 2 and 3 from baseline.

* Group 3 (after 3 years but before the end of the fifth year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1 and 2 from baseline (for patients in 4th year of treatment) or year 1 from baseline (for patients in 5th year of treatment).

Patients undergo blood collection at baseline and periodically during study for biomarker correlative study.

PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2006-08-24
• Study First Submitted QC: 2006-08-24
• Study First Posted: 2006-08-29
• Primary Completion: 2008-05
• Study Completion: 2012-01
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-26
• Last Update Posted: 2012-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 458

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamoxifen for 5 years	laboratory biomarker analysis	Patients treated with tamoxifen for 5 years after randomisation.
Tamoxifen for 5 years	Dual energy X-ray absorptiometry (DEXA)	Patients treated with tamoxifen for 5 years after randomisation.
Tamoxifen for 5 years	Spine X-ray	Patients treated with tamoxifen for 5 years after randomisation.
Letrozole for 5 years	laboratory biomarker analysis	Patients treated with letrozole for 5 years after randomisation.
Letrozole for 5 years	Dual energy X-ray absorptiometry (DEXA)	Patients treated with letrozole for 5 years after randomisation.
Letrozole for 5 years	Spine X-ray	Patients treated with letrozole for 5 years after randomisation.
Tamoxifen 2 years plus letrozole 3 years	laboratory biomarker analysis	Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
Tamoxifen 2 years plus letrozole 3 years	Dual energy X-ray absorptiometry (DEXA)	Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
Tamoxifen 2 years plus letrozole 3 years	Spine X-ray	Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
Letrozole 2 years plus tamoxifen 3 years	laboratory biomarker analysis	Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
Letrozole 2 years plus tamoxifen 3 years	Spine X-ray	Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
Letrozole 2 years plus tamoxifen 3 years	Dual energy X-ray absorptiometry (DEXA)	Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.

Primary Outcome Measures

Name	Time	Method
Relative percent change of bone mineral density (BMD) form baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98	5 years after randomisation to BIG 1-98
Recovery of BMD at 1 year after the completion of treatment on protocol IBCSG-1-98	6 years after randomisation to BIG 1-98
Proportion of patients with BMD below the absolute threshold value for osteoporosis	5 years after randomisation to BIG 1-98
Relative percent change in markers of bone resorption from baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98	5 years after randomisation to BIG 1-98
Recovery of the markers of bone resorption at 1 year after the completion of treatment on protocol IBCSG-1-98	6 years after randomisation to BIG 1-98

Trial Locations

Locations (16)

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

Regionalspital; 🇨🇭 Thun, Switzerland

Hospital Ruber Internacional; 🇪🇸 Madrid, Spain

Centro di Riferimento Oncologico - Aviano; 🇮🇹 Aviano, Italy

European Institute of Oncology; 🇮🇹 Milano, Italy

Dunedin Hospital; 🇳🇿 Dunedin, New Zealand

Instituto Nacional de Enfermedades Neoplasicas; 🇵🇪 Lima, Peru

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy

Institut Bergonie; 🇫🇷 Bordeaux, France

Ospedale Beata Vergine; 🇨🇭 Mendrisio, Switzerland

Institute of Oncology at Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia

Royal Brisbane and Women's Hospital; 🇦🇺 Brisbane, Queensland, Australia

Inselspital Bern; 🇨🇭 Bern, Switzerland

Groote Schuur Hospital; 🇿🇦 Cape Town, South Africa

Kantonspital Aarau; 🇨🇭 Aarau, Switzerland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland