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

NCT00963417 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2025-07-14

No results posted yet for this study

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).

Conditions

Interventions

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).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Breast International Group

    collaborator OTHER
  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Olivia Pagani, MD · Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-03
Primary Completion
2011-03-11
Completion
2024-10-23

Countries

  • Australia
  • Belgium
  • Switzerland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00963417 on ClinicalTrials.gov