Systematic Reviews
Copyright ©The Author(s) 2016.
World J Clin Oncol. Aug 10, 2016; 7(4): 331-336
Published online Aug 10, 2016. doi: 10.5306/wjco.v7.i4.331
Table 1 Overview of clinical trials evaluating sorafenib in breast cancer treatment
Ref.RegimenStudy designNumber of patientsDisease stageToxicityClinical efficacy
Moreno-Aspitia et al[14]Sorafenib as monotherapyPhase II; 1 arm23Stage IVManageableLow
Bianchi et al[15]Sorafenib as monotherapyPhase II; 1 arm54Stage IVManageableLow
Gradishar et al[16]Sorafenib + paclitaxelRCT (vs placebo)237Stage IVManageableBetter TTP
NCT00622466 (ongoing)[17]Sorafenib + paclitaxelRCT (vs placebo)41Stage IVNANA
NCT00499525 (ongoing)[17]Sorafenib + paclitaxelRCT (vs placebo)180Stages III-IVNANA
Mariani et al[18]Sorafenib + docetaxel and/or letrozoleRCT (vs placebo)218Stage IVManageableNot better
Baselga et al[19]Sorafenib + capecitabineRCT (vs placebo)229Stage IVHighBetter PFS
Baselga et al[20] (ongoing)Sorafenib + capecitabineRCT (vs placebo)519Stage IVNANA
Schwartzberg et al[21]Sorafenib + gemcitabine and/or capecitabineRCT (vs placebo)160Stages III-IVManageableBetter PFS
Luu et al[22]Sorafenib + vinorelbinePhase I/II; 1 arm11/35Stage IVManageableLow
Mina et al[23]Sorafenib + bevacizumabPhase II; 1 arm18Stage IVSubstantialLow
NCT02624700 (ongoing)[17]Sorafenib + pemetrexedPhase II; 1 arm35Stage IVNANA
Yardley et al[24]Sorafenib + ixabepilonePhase I/II; 1 arm10/76Stage IVHighLow
Isaacs et al[25]Sorafenib + anastrozolePhase I/II; 1 arm35Stage IVHighBenefit 23%
Massarweh et al[26]Sorafenib + endocrine therapy1Phase II; 1 arm11Stage IVManageablePromising4
NCT00634634 (ongoing)[17]Sorafenib + letrozolePhase I/II; 1 arm54Stage IVNANA
NCT01724606 (ongoing)[17]Sorafenib + WBRTPhase I24Stage IVNANA
NCT01621906 (ongoing)[17]Sorafenib + WBRT (18F-FLT-PET vs MRI)Diagnostic20Stage IVNANA
Spigel et al[27]Sorafenib + AC-T2One arm45Stages I-IIILimitedNA
Loibl et al[28]Sorafenib + EC-T3Phase II36Stages II-IIIManageablepCR 27.7%
Bazzola et al[29]Sorafenib + letrozole + cyclophosphamide3One arm13Stages II-IIITolerableClinical /no pCR