| General information |
| Database: | DB01081 |
| Objective: | Currently, antiangiogenic strategies in metastatic breast cancer have demonstrated modest improvements in progression free survival (PFS) but not improved quality or duration of survival, warranting evaluation of new agents in a placebocontrolled setting. Ramucirumab is a human immunoglobulin G1 antibody that binds vascular endothelial growth factor receptor2 and blocks ligandstimulated activation. The ROSE/TRIO012 trial evaluated ramucirumab with docetaxel in unresectable, locally recurrent, or metastatic breast cancer. |
| Authors: | Mackey JR, et al |
| Title: | Primary results of ROSE/TRIO12, a randomized placebocontrolledphase III trial evaluating the addition of ramucirumab to firstline docetaxel chemotherapy in metastatic breast cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2015 |
| PMID: | 25185099 |
| Trial Design |
| Clinical Trial Id: | NCT00703326 |
| Agent: | ramucirumab
|
| Target: | Vascular endothelial growth factor receptor 2
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | human epidermal growth factor receptor 2 (human epidermal growth factor receptor 2) negative breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | docetaxel+ ramucirumab |
| Study Type: | a doubleblind, placebocontrolled, randomized, multinationalphase III trial |
| Key Patients Feature: | patients with human epidermal growth factor receptor 2 (human epidermal growth factor receptor 2) negative breast cancer who had not received cytotoxic chemotherapy in the advanced setting |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | docetaxel+ placebo |
| Treatment Info: | patients were randomly assigned at a twotoone ratio to receive docetaxel 75 mg/m(2) plus ramucirumab 10 mg/kg or docetaxel 75 mg/m(2) plus placebo once every 3 weeks. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria |
| Primary End Point: | investigatorassessed PFS. |
| Secondary End Point: | NA |
| Patients Number: | 1144 |
| 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 in patients treated with ramucirumab plus docetaxel was 9.5 months, compared with 8.2 months in patients who received placebo plus docetaxel (hazard ratio [HR], 0.88; P = .077). |
| Median OS A vs. C: | Median overall survival was 27.3 months in patients who received ramucirumab plus docetaxel, compared with 27.2 months in patients who received placebo plus docetaxel (HR, 1.01; P = .915). |
| Adverse Event(agent arm): | Toxicities seen at significantly higher rates in patients receiving ramucirumab included fatigue, hypertension, febrile neutropenia, palmarplantar erythrodysesthesia syndrome, and stomatitis. |
| Conclusions: | Addition of ramucirumab to docetaxel in human epidermal growth factor receptor 2negative advanced breast cancer did not meaningfully improve important clinical outcomes. |