drugset / Trial / NCT01401062
Fresolimumab and Radiotherapy in Metastatic Breast Cancer
Phase 2
Completed
23 enrolled
Weill Medical College of Cornell University
University of California, Los Angeles · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to test safety of combining fresolimumab and local radiotherapy and to see if the combination can achieve tumor regression.
Timeline
- Start
- 2011-07
- Primary completion
- 2014-06
- Completion
- 2014-06
Publications
- Background Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbe C, Maio M, Binder M, Bohnsack O, Nichol G, Humphrey R, Hodi FS. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009 Dec 1;15(23):7412-20. doi: 10.1158/1078-0432.CCR-09-1624. Epub 2009 Nov 24.
- Formenti SC, Hawtin RE, Dixit N, Evensen E, Lee P, Goldberg JD, Li X, Vanpouille-Box C, Schaue D, McBride WH, Demaria S. Baseline T cell dysfunction by single cell network profiling in metastatic breast cancer patients. J Immunother Cancer. 2019 Jul 11;7(1):177. doi: 10.1186/s40425-019-0633-x.
- Sato M, Kadota M, Tang B, Yang HH, Yang YA, Shan M, Weng J, Welsh MA, Flanders KC, Nagano Y, Michalowski AM, Clifford RJ, Lee MP, Wakefield LM. An integrated genomic approach identifies persistent tumor suppressive effects of transforming growth factor-beta in human breast cancer. Breast Cancer Res. 2014 Jun 2;16(3):R57. doi: 10.1186/bcr3668.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fresolimumab | Protein / enzyme biologic | 1 mg/kg | Intravenous |
| Subject | Fresolimumab | Protein / enzyme biologic | 10 mg/kg | Intravenous |