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Sponsored by: |
University of Sheffield |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00072020 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Metastatic Cancer |
Drug: zoledronic acid Procedure: adjuvant therapy Procedure: neoadjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Does Adjuvant Zoledronic Acid Reduce Recurrence in Patients With High Risk Localized Breast Cancer? |
Study Start Date: | August 2003 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
Study ID Numbers: | CDR0000335111, SHEFF-AZURE, EU-20315, ISRCTN79831382, BIG-1-04 |
Study First Received: | November 4, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00072020 |
Health Authority: | United States: Federal Government |
bone metastases stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Zoledronic acid Skin Diseases Neoplasm Metastasis |
Breast Neoplasms Breast Diseases Recurrence |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |