drugset / Trial / NCT00127205
S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.
Phase 3
Completed
6097 enrolled
SWOG Cancer Research Network
Cancer and Leukemia Group B · collabEastern Cooperative Oncology Group · collabNCIC Clinical Trials Group · collabNSABP Foundation Inc · collabNational Cancer Institute (NCI) · collabNorth Central Cancer Treatment Group · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-07
- Primary completion
- 2017-12
- Completion
- 2021-03-29
Publications
- Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
- 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. 2021 May;29(5):2509-2517. doi: 10.1007/s00520-020-05748-8. Epub 2020 Sep 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibandronate | Other / unclassified | — | Oral |
| Subject | Zoledronic acid | Other / unclassified | — | Intravenous |
| Comparator | clodronate | Small molecule | — | Oral |