S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.
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ClinicalTrials.gov Identifier: NCT00127205 |
Recruitment Status :
Active, not recruiting
First Posted : August 5, 2005
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2020
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Tracking Information | ||||||||||||||||||||||
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First Submitted Date ICMJE | August 3, 2005 | |||||||||||||||||||||
First Posted Date ICMJE | August 5, 2005 | |||||||||||||||||||||
Results First Submitted Date ICMJE | June 20, 2019 | |||||||||||||||||||||
Results First Posted Date ICMJE | August 28, 2019 | |||||||||||||||||||||
Last Update Posted Date | August 28, 2020 | |||||||||||||||||||||
Study Start Date ICMJE | July 2005 | |||||||||||||||||||||
Actual Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | |||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Disease-free Survival [ Time Frame: Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence ] Time from date of registration to date of first observation of recurrence or death due to any cause. Patients last known to be alive who have not experienced recurrence of disease are censored at their last contact date. The outcome for the disease-free survival will be presented as 5 year survival rate.
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Original Primary Outcome Measures ICMJE | Not Provided | |||||||||||||||||||||
Change History | ||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||||||||
Descriptive Information | ||||||||||||||||||||||
Brief Title ICMJE | S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer. | |||||||||||||||||||||
Official Title ICMJE | Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer | |||||||||||||||||||||
Brief Summary | 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. |
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Detailed Description | 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 5,400 will be accrued for this study. |
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Study Type ICMJE | Interventional | |||||||||||||||||||||
Study Phase ICMJE | Phase 3 | |||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | |||||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Kizub DA, Miao J, Schubert MM, Paterson AHG, Clemons M, Dees EC, Ingle JN, Falkson CI, Barlow WE, Hortobagyi GN, Gralow JR. Risk factors for bisphosphonate-associated osteonecrosis of the jaw in the prospective randomized trial of adjuvant bisphosphonates for early-stage breast cancer (SWOG 0307). Support Care Cancer. 2020 Sep 15. doi: 10.1007/s00520-020-05748-8. [Epub ahead of print] | |||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | |||||||||||||||||||||
Actual Enrollment ICMJE |
6097 | |||||||||||||||||||||
Original Enrollment ICMJE | Not Provided | |||||||||||||||||||||
Estimated Study Completion Date ICMJE | January 2021 | |||||||||||||||||||||
Actual Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | |||||||||||||||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||||||||
Listed Location Countries ICMJE | Not Provided | |||||||||||||||||||||
Removed Location Countries | Canada, United States | |||||||||||||||||||||
Administrative Information | ||||||||||||||||||||||
NCT Number ICMJE | NCT00127205 | |||||||||||||||||||||
Other Study ID Numbers ICMJE | CDR0000437061 S0307 ( Other Identifier: SWOG ) |
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Has Data Monitoring Committee | Yes | |||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||||||||
Responsible Party | Southwest Oncology Group | |||||||||||||||||||||
Study Sponsor ICMJE | Southwest Oncology Group | |||||||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Southwest Oncology Group | |||||||||||||||||||||
Verification Date | August 2020 | |||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |