S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.
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
Outcome
Missed primary endpoint
registry analysis (superiority test); Arm I Zoledronate vs Arm II Clodronate; p = 0.24; Hazard Ratio (HR) 1.09 (95% CI 0.94 to 1.26); Regression, Cox NCT00127205 ↗
registry analysis (superiority test); Arm I Zoledronate vs Arm III Ibandronate; p = 0.50; Hazard Ratio (HR) 1.06 (95% CI 0.90 to 1.24); Regression, Cox NCT00127205 ↗
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 |