Clinical trial NCT00963417: Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: ETOP IBCSG Partners Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: Breast International Group
First posted: 2009-08-21
Enrollment: 119
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase
timeFrame: 72 months after rnadomization to TEXT Study
measure: Serial serum levels of IGF-1 and IGFBP-3
timeFrame: 72 months after randomization to TEXT Study
measure: Serial BMD measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA)
timeFrame: 72 months after randomization to TEXT Study
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Center
city: Melbourne
country: Australia
facility: Box Hill Hospital
city: Melbourne
country: Australia
facility: Maroondah Hospital
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Huy
country: Belgium
facility: Centre Hospitalier Regional de Huy
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: C.H.U. Sart Tilman
city: Liège
country: Belgium
facility: CHR Citadelle
city: Verviers
country: Belgium
facility: C.H.P.L.T. de Verviers
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland
city: Bern
country: Switzerland
facility: Inselspital Bern
city: St.Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
Study officials:
affiliation: Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
name: Olivia Pagani, MD
role: STUDY_CHAIR
References: