A Phase 3 interventional study of zoledronic acid and adjuvant therapy in Breast Cancer and Metastatic Cancer, sponsored by University of Sheffield. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-02.
Sponsored by University of Sheffield · Phase 3, Interventional, and Treatment
RATIONALE: Zoledronate may delay or prevent the formation of bone metastases. It is not yet known whether chemotherapy and/or hormone therapy are more effective with or without zoledronate in preventing cancer recurrence and bone metastases in women with breast cancer.
PURPOSE: This randomized phase III trial is studying giving chemotherapy and/or hormone therapy together with zoledronate to see how well they work compared to chemotherapy and/or hormone therapy alone in preventing cancer recurrence and bone metastases in women with stage II or stage III breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, parallel-group, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed annually for 5 years.
PROJECTED ACCRUAL: A total of 3,300 patients (1,650 per treatment arm) will be accrued for this study within 3 years.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
Browse Breast Neoplasms studies →University of Sheffield is the lead sponsor of 74 studies on the registry; 16 are open to participants now.
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DISEASE CHARACTERISTICS:
Diagnosis of primary breast cancer, meeting 1 of the following staging criteria:
Receiving OR scheduled to receive chemotherapy and/or endocrine therapy
For patients receiving neoadjuvant therapy
For patients receiving adjuvant therapy
NOTE: **Preoperative endocrine therapy with a duration of \< 30 days is not considered prior neoadjuvant therapy
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No history of disease with influence on bone metabolism, including any of the following:
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
More than 4 weeks since prior and no concurrent dental or jaw surgery (e.g., extractions or implants)
Other
Disease-free survival as assessed annually for 10 years
Time to bone metastases as first recurrence assessed annually for 10 years
Time to bone metastases per se as assessed annually for 10 years
Time to distant metastases as assessed annually for 10 years
Overall survival as assessed by final analysis at 10 years
Skeletal-related events prior to development of bone metastases as assessed annually for 10 years
Skeletal-related events following development of bone metastases as assessed annually for 10 years
Safety and toxicity of zoledronic acid as assessed annually for 10 years
Evaluation of the influence of prognostic factors (e.g., estrogen receptor or progesterone receptor [ER/PR] status, TNM stage, tumor grade, HER2/neu, and menopausal status) on treatment outcome
Analysis of tumor-specific mutations, proteomics and gene expression changes in tumor cells
No study locations are listed for this record.
This study is status unknown, as verified in Jan 2006. You cannot join it, but the record below documents what was studied.
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University of Sheffield