Trial reportInvestigational new drugs2013
A phase II study of combined VEGF inhibitor (bevacizumab+sorafenib) in patients with metastatic breast cancer: Hoosier Oncology Group Study BRE06-109.
Trial report in Investigational new drugs, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00632541 (A Phase II Study of Combined VEGF Inhibitor), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II Study of Combined VEGF Inhibitor (Bevacizumab + Sorafenib) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE06-109
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.
- Vascular endothelial growth factor (VEGF) antibody significantly increases the risk of hand-foot skin reaction to multikinase inhibitors (MKIs): A systematic literature review and meta-analysis.Clinical and experimental pharmacology & physiology · 2018Pooled it
- Inefficiencies and Patient Burdens in the Development of the Targeted Cancer Drug Sorafenib: A Systematic Review.PLoS biology · 2017Pooled it
- Assessing patient risk, benefit, and outcomes in drug development: a decade of sorafenib clinical trials.European journal of clinical pharmacology · 2026Review
- Phase I study of cediranib, an oral VEGFR inhibitor, in combination with selumetinib, an oral MEK inhibitor, in patients with advanced solid malignancies.Investigational new drugs · 2022Article
- Phase I, Pharmacogenomic, Drug Interaction Study of Sorafenib and Bevacizumab in Combination with Paclitaxel in Patients with Advanced Refractory Solid Tumors.Molecular cancer therapeutics · 2020Article
- Phase I dose-escalation study of pazopanib combined with bevacizumab in patients with metastatic renal cell carcinoma or other advanced tumors.BMC cancer · 2017Article
- Sorafenib in breast cancer treatment: A systematic review and overview of clinical trials.World journal of clinical oncology · 2016Article
- Targeted therapy in ovarian cancer.Women's health (London, England) · 2016Review
- Dosing de novo combinations of two targeted drugs: Towards a customized precision medicine approach to advanced cancers.Oncotarget · 2016Article
- Phase I trial of FOLFIRI in combination with sorafenib and bevacizumab in patients with advanced gastrointestinal malignancies.Investigational new drugs · 2016Article
- Article
- Article
- Cisplatin induced sensory neuropathy is prevented by vascular endothelial growth factor-A.American journal of translational research · 2015Article
- Efficacy and Safety Profile of Combining Sorafenib with Chemotherapy in Patients with HER2-Negative Advanced Breast Cancer: A Meta-analysis.Journal of breast cancer · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeAngiogenesis plays an essential role in tumor development, invasion and metastasis. We evaluated the efficacy and safety of dual angiogenesis blockade with bevacizumab and sorafenib in patients with metastatic breast cancer. PATIENTS AND
methodsPatients who had received no more than 2 prior chemotherapy regimens in any setting were treated with sorafenib 200 mg as a single oral dose daily plus bevacizumab intravenously 5 mg/kg every other week. Response was assessed by Response Evaluation Criteria in Solid Tumors (RECIST). The primary endpoint was progression free survival (PFS).
resultsEighteen patients were enrolled. Median age was 56 yo, all had good performance status KPS of 0 or 1, and 17 patients had received 1 or 2 prior chemotherapy regimens. Median PFS was 2.8 months. There were no complete or partial responses; 3 patients had stable disease for >6 months. Toxicity was substantial with 9 (50 %) patients reporting Grade 3 toxicity. Seven (39 %) patients discontinued therapy due to adverse events including hypertension (N=2), GI toxicity (N=1), sensory neuropathy (N=1), rash (N=1), pain (N=1) and wound complication (N=1). Given the lack of clear efficacy and increased toxicity, accrual was terminated.
conclusionThe combination of sorafenib and bevacizumab has substantial toxicity and minimal efficacy in patients with previously treated metastatic breast cancer. Further study of this combination is not recommended.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.