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Clinical experience with ramucirumab : outcomes in breast cancer
Geraldine O'Sullivan Coyne1, Mauricio Burotto
1National Cancer Institute, National Institutes of Health National, Center for Cancer Research, Medical Oncology Service , 12N226, Bethesda, MD 20892 , USA +1 301 496 4916 ; +1 301 402 0172 ; geraldine.o'sullivancoyne@nih.gov.
Introduction:
Monoclonal antibodies and small molecules targeting the VEGF pathway are part of the arsenal to treat malignant tumors. Antiangiogenesis therapies has been studied in breast cancer with partial success, reflected by the approval of bevacizumab in Europe but not in United States, for metastatic breast cancer (mBC). Ramucirumab is a mAb against VEGFR-2 interfering with the normal activation of this receptor by its natural ligand VEGF.
Areas Covered:
This article will review the preclinical data available to date for ramucirumab, as well as survey the main clinical trials of antiangiogenic agents reported in breast cancer, focusing on Phase III clinical trials. It will also review the clinical trial data for ramucirumab in mBC, including the design of the Phase II trials, and report on the preliminary results of the TRIO-012 trial. This trial did not meet its primary end point in progression-free survival and has to be considered as a negative trial.
Expert Opinion:
Despite preliminary positive data with ramucirumab in other metastatic solid tumors reported to date, the results of TRIO-012 discourage pursuing more efforts with ramucirumab in mBC unless predictive and reproducible biomarkers can be established to select those patients who are most likely to benefit from it.
Insights
Ramucirumab, an anti-VEGFR-2 monoclonal antibody, showed negative results in a Phase III trial for metastatic breast cancer (mBC). Further investigation in mBC is not recommended without predictive biomarkers.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Antiangiogenesis therapies targeting the VEGF pathway are used in cancer treatment.
- Ramucirumab is a monoclonal antibody (mAb) targeting VEGFR-2, inhibiting VEGF signaling.
- Antiangiogenesis agents have shown limited success in metastatic breast cancer (mBC).
Purpose of the Study:
- To review preclinical data for ramucirumab.
- To survey clinical trials of antiangiogenic agents in breast cancer, focusing on Phase III trials.
- To analyze ramucirumab's clinical trial data in mBC, including the TRIO-012 trial results.
Main Methods:
- Review of preclinical data for ramucirumab.
- Survey of published Phase III clinical trials for antiangiogenic agents in breast cancer.
- Analysis of Phase II and preliminary Phase III (TRIO-012) trial data for ramucirumab in mBC.
Main Results:
- The TRIO-012 trial, evaluating ramucirumab in mBC, did not meet its primary endpoint of progression-free survival.
- Preliminary results indicate ramucirumab's efficacy in mBC is not established by this trial.
- Ramucirumab has shown preliminary positive data in other metastatic solid tumors.
Conclusions:
- The negative outcome of the TRIO-012 trial discourages further development of ramucirumab in mBC.
- Future efforts require the identification of predictive biomarkers to select patients likely to benefit from ramucirumab.
- Biomarker development is crucial for the potential success of ramucirumab in mBC.
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