Sorafenib in breast cancer treatment: A systematic review and overview of clinical trials

Table 1 Overview of clinical trials evaluating sorafenib in breast cancer treatment

Ref.	Regimen	Study design	Number of patients	Disease stage	Toxicity	Clinical efficacy
Moreno-Aspitia et al[14]	Sorafenib as monotherapy	Phase II; 1 arm	23	Stage IV	Manageable	Low
Bianchi et al[15]	Sorafenib as monotherapy	Phase II; 1 arm	54	Stage IV	Manageable	Low
Gradishar et al[16]	Sorafenib + paclitaxel	RCT (vs placebo)	237	Stage IV	Manageable	Better TTP
NCT00622466 (ongoing)[17]	Sorafenib + paclitaxel	RCT (vs placebo)	41	Stage IV	NA	NA
NCT00499525 (ongoing)[17]	Sorafenib + paclitaxel	RCT (vs placebo)	180	Stages III-IV	NA	NA
Mariani et al[18]	Sorafenib + docetaxel and/or letrozole	RCT (vs placebo)	218	Stage IV	Manageable	Not better
Baselga et al[19]	Sorafenib + capecitabine	RCT (vs placebo)	229	Stage IV	High	Better PFS
Baselga et al[20] (ongoing)	Sorafenib + capecitabine	RCT (vs placebo)	519	Stage IV	NA	NA
Schwartzberg et al[21]	Sorafenib + gemcitabine and/or capecitabine	RCT (vs placebo)	160	Stages III-IV	Manageable	Better PFS
Luu et al[22]	Sorafenib + vinorelbine	Phase I/II; 1 arm	11/35	Stage IV	Manageable	Low
Mina et al[23]	Sorafenib + bevacizumab	Phase II; 1 arm	18	Stage IV	Substantial	Low
NCT02624700 (ongoing)[17]	Sorafenib + pemetrexed	Phase II; 1 arm	35	Stage IV	NA	NA
Yardley et al[24]	Sorafenib + ixabepilone	Phase I/II; 1 arm	10/76	Stage IV	High	Low
Isaacs et al[25]	Sorafenib + anastrozole	Phase I/II; 1 arm	35	Stage IV	High	Benefit 23%
Massarweh et al[26]	Sorafenib + endocrine therapy1	Phase II; 1 arm	11	Stage IV	Manageable	Promising4
NCT00634634 (ongoing)[17]	Sorafenib + letrozole	Phase I/II; 1 arm	54	Stage IV	NA	NA
NCT01724606 (ongoing)[17]	Sorafenib + WBRT	Phase I	24	Stage IV	NA	NA
NCT01621906 (ongoing)[17]	Sorafenib + WBRT (18F-FLT-PET vs MRI)	Diagnostic	20	Stage IV	NA	NA
Spigel et al[27]	Sorafenib + AC-T2	One arm	45	Stages I-III	Limited	NA
Loibl et al[28]	Sorafenib + EC-T3	Phase II	36	Stages II-III	Manageable	pCR 27.7%
Bazzola et al[29]	Sorafenib + letrozole + cyclophosphamide3	One arm	13	Stages II-III	Tolerable	Clinical /no pCR

¹Tamoxifen or anastrozole or letrozole or exemestane or fluvestrant;

²Adjuvant;

³Neoadjuvant;

⁴With tamoxifen. WBRT: Whole brain radiotherapy; NA: Not available; pCR: Pathological complete response; PET: Positron emission tomography; MRI: Magnetic resonance imaging.