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Study 18 of 752 for search of: | United States, South Dakota |
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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) North Central Cancer Treatment Group Eastern Cooperative Oncology Group National Surgical Adjuvant Breast and Bowel Project (NSABP) Cancer and Leukemia Group B National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00127205 |
RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer.
PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: clodronate disodium Drug: ibandronate sodium Drug: zoledronic acid |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer |
Estimated Enrollment: | 4500 |
Study Start Date: | July 2005 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.
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Drug: zoledronic acid
Given IV
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Arm II: Active Comparator
Patients receive oral clodronate once daily for 3 years.
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Drug: clodronate disodium
Given orally
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Arm III: Experimental
Patients receive oral ibandronate once daily for 3 years.
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Drug: ibandronate sodium
Given orally
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OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
After completion of study treatment, patients are followed every 6 months until disease recurrence and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 4,500 will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary adenocarcinoma of the breast
Must have undergone lumpectomy or total mastectomy for primary disease within the past 12 weeks, or have completed chemotherapy within the past 8 weeks
Currently receiving or planning to receive standard adjuvant systemic therapy comprising chemotherapy, hormonal therapy, or combined chemotherapy/hormonal therapy for breast cancer
Patients with skeletal pain are eligible provided bone scan and/or roentgenological exam are negative for metastatic disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No history of esophageal stricture or motility disorders
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent enrollment in clinical trials with bone density as an endpoint
Investigator: | Julie R. Gralow, MD | Seattle Cancer Care Alliance |
Investigator: | Robert B. Livingston, MD | University of Arizona |
Investigator: | James N. Ingle, MD | Mayo Clinic |
Investigator: | Carla I. Falkson, MD | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
Investigator: | Alexander H. G. Paterson, MD, FRCP, FACP, MBChB | Tom Baker Cancer Centre - Calgary |
Investigator: | Elizabeth C. Dees, MD | UNC Lineberger Comprehensive Cancer Center |
Investigator: | Mark J. Clemons, MD | Edmond Odette Cancer Centre at Sunnybrook |
Study ID Numbers: | CDR0000437061, SWOG-S0307, NCCTG-SWOG-S0307, ECOG-SWOG-S0307, NSABP-SWOG-S0307, CALGB-SWOG-S0307, CAN-NCIC-SWOG-S0307 |
Study First Received: | August 3, 2005 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00127205 |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Clodronic Acid Diphosphonates Zoledronic acid Ibandronic acid |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |