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

Primary Purpose

Breast Cancer, Osteoporosis

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
laboratory biomarker analysis
dual x-ray absorptiometry
Sponsored by
ETOP IBCSG Partners Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Brisbane and Women's Hospital
  • Peter MacCallum Cancer Center
  • Box Hill Hospital
  • Maroondah Hospital
  • Royal Perth Hospital
  • Centre Hospitalier Regional de Huy
  • UZ Leuven
  • C.H.U. Sart Tilman
  • CHR Citadelle
  • C.H.P.L.T. de Verviers
  • Oncology Institute of Southern Switzerland
  • Inselspital Bern
  • Kantonsspital St.Gallen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Triptorelin plus tamoxifen

Triptorelin plus exemestane

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase
Serial serum levels of IGF-1 and IGFBP-3
Serial BMD measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA)

Secondary Outcome Measures

Full Information

First Posted
August 20, 2009
Last Updated
May 30, 2023
Sponsor
ETOP IBCSG Partners Foundation
Collaborators
National Cancer Institute (NCI), Breast International Group
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1. Study Identification

Unique Protocol Identification Number
NCT00963417
Brief Title
Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 3, 2009 (Actual)
Primary Completion Date
March 11, 2011 (Actual)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ETOP IBCSG Partners Foundation
Collaborators
National Cancer Institute (NCI), Breast International Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triptorelin plus tamoxifen
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Triptorelin plus exemestane
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.
Intervention Type
Procedure
Intervention Name(s)
dual x-ray absorptiometry
Intervention Description
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).
Primary Outcome Measure Information:
Title
Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase
Time Frame
72 months after rnadomization to TEXT Study
Title
Serial serum levels of IGF-1 and IGFBP-3
Time Frame
72 months after randomization to TEXT Study
Title
Serial BMD measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA)
Time Frame
72 months after randomization to TEXT Study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivia Pagani, MD
Organizational Affiliation
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
Country
Australia
Facility Name
Peter MacCallum Cancer Center
City
East Melbourne
Country
Australia
Facility Name
Box Hill Hospital
City
Melbourne
Country
Australia
Facility Name
Maroondah Hospital
City
Melbourne
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
Country
Australia
Facility Name
Centre Hospitalier Regional de Huy
City
Huy
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
C.H.U. Sart Tilman
City
Liège
Country
Belgium
Facility Name
CHR Citadelle
City
Liège
Country
Belgium
Facility Name
C.H.P.L.T. de Verviers
City
Verviers
Country
Belgium
Facility Name
Oncology Institute of Southern Switzerland
City
Bellinzona
ZIP/Postal Code
CH-6500
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
Country
Switzerland
Facility Name
Kantonsspital St.Gallen
City
St.Gallen
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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