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

NCT ID: NCT00963417

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-03
• Study Completion Date: 2024-10-23

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).

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.

Conditions

Breast Cancer; Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

laboratory biomarker analysis

Intervention Type: OTHER

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

dual x-ray absorptiometry

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

laboratory biomarker analysis

Intervention Type: OTHER

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

dual x-ray absorptiometry

Intervention Type: 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).

Interventions

laboratory biomarker analysis

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

Intervention Type: OTHER

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).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Breast International Group

OTHER

Sponsor Role: collaborator

ETOP IBCSG Partners Foundation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivia Pagani, MD

Role: STUDY_CHAIR

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Locations

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

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

Oncology Institute of Southern Switzerland

Bellinzona, , Switzerland

Inselspital Bern

Bern, , Switzerland

Kantonsspital St.Gallen

Sankt Gallen, , Switzerland

Countries

Australia; Belgium; Switzerland

Other Identifiers

IBCSG-25A-02

Identifier Type: -

Identifier Source: secondary_id

BIG-25A-02

Identifier Type: -

Identifier Source: secondary_id

NABCI-IBCSG-25A-02

Identifier Type: -

Identifier Source: secondary_id

CDR0000637437

Identifier Type: -

Identifier Source: org_study_id