drugset / Trial / NCT00248703
Secondary Adjuvant Treatment for Patients With Isolated Tumor Cells in Bone Marrow
Phase 2
Completed
1128 enrolled
Oslo University Hospital
Alesund Hospital · collabHelse Stavanger HF · collabSorlandet Hospital HF · collabSykehuset Innlandet HF · collabSykehuset Ostfold · collabSykehuset i Vestfold HF · collabUllevaal University Hospital · collabUniversity of Tromso · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to identify patients with persisting tumor cells after standard epirubicin-containing treatment to test a non-cross resistant chemotherapy regimen (docetaxel) for these patients, and to explore the analysis of disseminated tumor cells in bone marrow as a surrogate marker for clinical outcome.
Timeline
- Start
- 2003-10
- Primary completion
- 2012-11
- Completion
- 2022-04
Publications
- Naume B, Synnestvedt M, Falk RS, Wiedswang G, Weyde K, Risberg T, Kersten C, Mjaaland I, Vindi L, Sommer HH, Saetersdal AB, Rypdal MC, Bendigtsen Schirmer C, Wist EA, Borgen E. Clinical outcome with correlation to disseminated tumor cell (DTC) status after DTC-guided secondary adjuvant treatment with docetaxel in early breast cancer. J Clin Oncol. 2014 Dec 1;32(34):3848-57. doi: 10.1200/JCO.2014.56.9327. Epub 2014 Nov 3.
- Gilje B, Nordgard O, Tjensvoll K, Borgen E, Synnestvedt M, Smaaland R, Naume B. Comparison of molecular and immunocytochemical methods for detection of disseminated tumor cells in bone marrow from early breast cancer patients. BMC Cancer. 2014 Jul 15;14:514. doi: 10.1186/1471-2407-14-514.
- Synnestvedt M, Borgen E, Wist E, Wiedswang G, Weyde K, Risberg T, Kersten C, Mjaaland I, Vindi L, Schirmer C, Nesland JM, Naume B. Disseminated tumor cells as selection marker and monitoring tool for secondary adjuvant treatment in early breast cancer. Descriptive results from an intervention study. BMC Cancer. 2012 Dec 22;12:616. doi: 10.1186/1471-2407-12-616.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 100 mg/m2 | — |