| General information |
| Database: | DB01033 |
| Objective: | study of combined VEGF inhibitor (bevacizumab+sorafenib) in patients with metastatic breast cancer |
| Authors: | Lida A. Mina |
| Title: | a phase II study of combined VEGF inhibitor (bevacizumab+sorafenib) in patients with metastatic breast cancer: Hoosier Oncology Group Study BRE06109. |
| Journal: | Investigational New Drugs |
| Year: | 2013 |
| PMID: | 23812905 |
| Trial Design |
| Clinical Trial Id: | NCT00632541 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | bevacizumab+sorafenib |
| Study Type: | a phase II study of bevacizumab + sorafenib in metastatic breast cancer; singlearm |
| Key Patients Feature: | more than and equal to 18 years old, had histologically confirmed adenocarcinoma of the breast with evidence of metastatic disease, measurable according to RECIST 1.0 criteria. patients were also required to have an ECOG performance status of 0 or 1 as well as adequate hematologic, renal and hepatic function. Patients with human epidermal growth factor receptor 2 positive (3+ by immunohistochemistry or gene amplification by fluorescence in situ hybridization) disease must have received prior trastuzumab therapy. Patients could not have received more than 2 prior chemotherapy regimens, considering all adjuvant and neoadjuvant therapy as one regimen. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | NA |
| Treatment Info: | sorafenib 200 mg as a single oral dose daily plus bevacizumab intravenously 5 mg/kg every other week. |
| Primary End Point: | progression free survival (PFS). |
| Secondary End Point: | overall response rate (ORR), clinical benefit response defined as the percentage of evaluable patients with confirmed complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months (CR+PR+SD), and safety. |
| Patients Number: | 18 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Median PFS was 2.8 months, 95 % CI (1.8-6.1). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | no grade 4 toxicity was noted, 9 (50 % of patients reported grade 3 toxicity. Hypertension was common with 14 (78 %) patients experiencing grade 2 or 3 toxicity. GI toxicity, sensory neuropathy, rash, and pain were also relatively common. Seven patients discontinued therapy due to toxicity; reasons for treatment discontinuation were uncontrolled hypertension (n=2), nausea (n=1), neuropathy (n=1), pain (n= 1), rash (n=1) and wound complications (n=1). One patient had a grade 3 hypersensitivity reaction; however patient was able to continue with treatment with premedication. No hematologic toxicities were reported, however elevation in the liver transaminases were noted in two patients. |
| Conclusions: | The combination ofsorafenib and bevacizumab has substantial toxicity and minimal efficacy in patients with previously treated metastatic breast cancer. Further study of this combination is not recommended. |