Related Experiment Video
Updated: May 22, 2026

An Oncogenic Hepatocyte-Induced Orthotopic Mouse Model of Hepatocellular Cancer Arising in the Setting of Hepatic Inflammation and Fibrosis
Published on: September 12, 2019
Sorafenib in locally advanced or metastatic breast cancer
1Maggie Daley Center for Women's Cancer Care, Northwestern University Feinberg School of Medicine, Northwestern Memorial Hospital, Robert H. Lurie Comprehensive Cancer Center, 676 N St Clair St, Suite 850, Chicago, IL 60611, USA. WGradishar@nmff.org
Introduction:
Sorafenib is an oral multikinase inhibitor with anti-angiogenic and anti-proliferative activity that is indicated for use in hepatocellular and renal cell carcinomas. Sorafenib is being developed in a number of solid tumors, including breast cancer (BC).
Areas Covered:
A series of four randomized, double-blind, placebo-controlled Phase IIb screening Trials were developed to Investigate the Efficacy of Sorafenib (TIES) when added to select chemotherapies for patients with HER2-negative advanced BC with a primary endpoint of progression-free survival (PFS). Results have been varied. SOLTI-0701 reported significant PFS benefit for sorafenib plus capecitabine as first- or second-line treatment, and AC01B07 reported a modest but significant PFS benefit when sorafenib was combined with gemcitabine or capecitabine for patients whose disease had progressed during or after bevacizumab. Sorafenib plus first-line paclitaxel did not significantly improve PFS (NU07B1 study), nor did its addition to first-line docetaxel and/or letrozole (FM-B07-01 study). A Phase III trial of sorafenib plus capecitabine has been initiated.
Expert Opinion:
Phase IIb data indicate a potential role for sorafenib in combination with select chemotherapies for HER2-negative advanced BC, but Phase III confirmatory trials are necessary. The variability in results across studies with sorafenib may be related to the chemotherapy combination and/or patient population.
Insights
Sorafenib shows varied efficacy in advanced HER2-negative breast cancer (BC) when combined with chemotherapy. Further Phase III trials are needed to confirm its role in specific patient populations and treatment regimens.
Area of Science:
- Oncology
- Medical Oncology
- Clinical Trials
Background:
- Sorafenib is an oral multikinase inhibitor with anti-angiogenic and anti-proliferative properties.
- Currently approved for hepatocellular and renal cell carcinomas, sorafenib is under investigation for other solid tumors, including breast cancer (BC).
Purpose of the Study:
- To investigate the efficacy of sorafenib when added to select chemotherapies for patients with HER2-negative advanced breast cancer.
- To evaluate the impact of sorafenib on progression-free survival (PFS) in this patient population.
Main Methods:
- Four randomized, double-blind, placebo-controlled Phase IIb screening trials (TIES) were conducted.
- Sorafenib was administered in combination with various chemotherapies (capecitabine, gemcitabine, paclitaxel, docetaxel, letrozole).
- Primary endpoint for all trials was progression-free survival (PFS).
Main Results:
- SOLTI-0701 showed significant PFS benefit with sorafenib plus capecitabine (first- or second-line).
- AC01B07 reported a modest PFS benefit with sorafenib plus gemcitabine or capecitabine after bevacizumab progression.
- NU07B1 and FM-B07-01 trials did not show significant PFS improvement with sorafenib combined with paclitaxel, docetaxel, or letrozole.
Conclusions:
- Phase IIb data suggest a potential role for sorafenib in combination with specific chemotherapies for HER2-negative advanced BC.
- Variability in results may be attributed to the chemotherapy combination used or specific patient populations.
- Phase III confirmatory trials are essential to validate these findings and establish sorafenib's role in advanced breast cancer treatment.
Related Concept Videos
Targeted Cancer Therapies
There are several types of targeted therapies against specific...
Targeted Cancer Therapies
There are several types of targeted therapies against specific...
Treatment Resistent Cancers
Treatment Resistant Cancers
mTOR Signaling and Cancer Progression
The mTOR pathway or the...
mTOR Signaling and Cancer Progression
The mTOR pathway or the...
