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

Breast Cancer Clinical Trial

— TEXT-Bone  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00963417
• Other study ID #: CDR0000637437
• Secondary ID: IBCSG-25A-02BIG-
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 3, 2009
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: ETOP IBCSG Partners Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 119
• Est. completion date: December 2025
• Est. primary completion date: March 11, 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Osteoporosis

Intervention

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).

Locations

Country	Name	City	State
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
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
Switzerland	Oncology Institute of Southern Switzerland	Bellinzona
Switzerland	Inselspital Bern	Bern
Switzerland	Kantonsspital St.Gallen	St.Gallen

Sponsors (3)

Lead Sponsor	Collaborator
ETOP IBCSG Partners Foundation	Breast International Group, National Cancer Institute (NCI)

Countries where clinical trial is conducted

Australia,  Belgium,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase		72 months after rnadomization to TEXT Study
Primary	Serial serum levels of IGF-1 and IGFBP-3		72 months after randomization to TEXT Study
Primary	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