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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00301886 |
Purpose
RATIONALE: Zoledronate and ibandronate may prevent or help relieve bone pain and other symptoms caused by bone metastases. It is not yet known whether zoledronate is more effective than ibandronate in preventing bone problems caused by bone metastases due to breast cancer.
PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to ibandronate in preventing bone problems in women with stage IV breast cancer that has spread to the bone.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Hypercalcemia of Malignancy Metastatic Cancer Pain |
Drug: ibandronate sodium Drug: zoledronic acid Procedure: quality-of-life assessment |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized |
| Official Title: | A Phase III Randomized, Multicenter Non-Inferiority Trial Evaluating the Efficacy of Oral Ibandronate Versus Intravenous Zoledronate in the Reduction of Skeletal-Related Events in Patients With Metastatic Breast Cancer |
| Estimated Enrollment: | 488 |
| Study Start Date: | May 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to hormone receptor status (estrogen receptor [ER] and progesterone receptor [PR] negative vs ER and/or PR positive) and current evidence of fracture (vertebral or nonvertebral) or spinal compression (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Quality of life and pain are assessed at baseline, every 3 courses during study treatment, and at the end of study treatment.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 488 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV breast cancer at primary diagnosis or at recurrence
At least 1 dominant osteolytic or osteoblastic or mixed metastatic lesion outside any prior radiation field
PATIENT CHARACTERISTICS:
No other prior malignancy except for the following:
No uncontrolled medical illness or infection, including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| Study Chair: | Saul E. Rivkin, MD | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus |
| Investigator: | Kathy S. Albain, MD | Loyola University |
| Investigator: | Dawn Hershman, MD | Herbert Irving Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000463758, SWOG-S0308 |
| Study First Received: | March 9, 2006 |
| Last Updated: | January 9, 2010 |
| ClinicalTrials.gov Identifier: | NCT00301886 History of Changes |
| Health Authority: | United States: Federal Government |
|
pain hypercalcemia of malignancy stage IV breast cancer bone metastases recurrent breast cancer |
|
Metabolic Diseases Zoledronic acid Skin Diseases Physiological Effects of Drugs Hypercalcemia Breast Neoplasms Bone Density Conservation Agents Pharmacologic Actions Calcium Metabolism Disorders |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Ibandronic acid Neoplasm Metastasis Water-Electrolyte Imbalance Breast Diseases |