drugset / Trial / NCT00593697
The Synergism Or Long Duration (SOLD) Study
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to compare disease-free survival (DFS) of women treated with concomitant trastuzumab plus docetaxel followed by FEC to that of the women treated with the same regimen followed by single-agent trastuzumab to complete one year of trastuzumab administration as adjuvant treatments of early HER2-positive breast cancer.
Timeline
- Start
- 2008-01
- Primary completion
- 2014-11
- Completion
- 2014-11
Publications
- Joensuu H, Fraser J, Wildiers H, Huovinen R, Auvinen P, Utriainen M, Villman KK, Halonen P, Granstam-Bjorneklett H, Tanner M, Sailas L, Turpeenniemi-Hujanen T, Yachnin J, Huttunen T, Neven P, Canney P, Harvey VJ, Kellokumpu-Lehtinen PL, Lindman H. Long-Term Outcomes of Adjuvant Trastuzumab for 9 Weeks or 1 Year for ERBB2-Positive Breast Cancer: A Secondary Analysis of the SOLD Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2429772. doi: 10.1001/jamanetworkopen.2024.29772.
- Joensuu H, Fraser J, Wildiers H, Huovinen R, Auvinen P, Utriainen M, Nyandoto P, Villman KK, Halonen P, Granstam-Bjorneklett H, Lundgren L, Sailas L, Turpeenniemi-Hujanen T, Tanner M, Yachnin J, Ritchie D, Johansson O, Huttunen T, Neven P, Canney P, Harvey VJ, Kellokumpu-Lehtinen PL, Lindman H. Effect of Adjuvant Trastuzumab for a Duration of 9 Weeks vs 1 Year With Concomitant Chemotherapy for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: The SOLD Randomized Clinical Trial. JAMA Oncol. 2018 Sep 1;4(9):1199-1206. doi: 10.1001/jamaoncol.2018.1380.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Docetaxel | Small molecule | 80 mg/m2 | — |
| Comparator | Docetaxel | Small molecule | 100 mg/m2 | — |
| Comparator | Trastuzumab | Monoclonal antibody | — | — |
| Comparator | Cyclophosphamide | Other / unclassified | — | — |
| Comparator | Epirubicin | Small molecule | — | — |
| Comparator | fluorouracil | Small molecule | — | — |