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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
December 2017
NCT00127205Uploaded 06-04-2021
Access via NCI by Request
PDS UID: nci-data-469
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
Provider Information
Provider Data DescriptionThere are two datasets associated with PMID 31693129: NCT00127205-D1 and NCT00127205-D2. This dataset, NCT00127205-D1, will allow users to reproduce the patient characteristics, treatment completion, and primary outcome results reported in J Natl Cancer Inst. (2020 Jul 1;112(7):698-707. doi: 10.1093/jnci/djz215. PMID: 31693129; PMCID: PMC7357327) for trial NCT00127205.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: 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.
ConditionsBreast Cancer
Intervention TypeDrug: clodronate disodium
Drug: ibandronate sodium
Drug: zoledronic acid
Drug(s)Drug: zoledronic acid
Drug: clodronate disodium
Drug: ibandronate sodium
Total Enrolled6097
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I - Experimental
Arm II - Active Comparator
Arm III - Experimental
Secondary IDS0307
PubMed (PMID)32929540
Collaborator(s)National Cancer Institute (NCI)
North Central Cancer Treatment Group
Eastern Cooperative Oncology Group
NSABP Foundation Inc
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Files: NCT00127205-D1
Data DictionaryNCT00127205-D1-Data-Dictionary_1.pdf
DATANCT00127205-D1-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00127205-D2
Data DictionaryNCT00127205-D2-Data-Dictionary_1.pdf
DATANCT00127205-D2-Dataset.csv
OTHERREADME.pdf
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