Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced Breast Cancer

Summary

The purpose of this study is Examination of the superiority of a combination of vinorelbine with the mTOR Inhibitor Everolimus vs. vinorelbine monotherapy for second-line treatment in advanced breast cancer.

Timeline

Start

2012-01

Primary completion

2016-10-31

Completion

2016-10-31

Outcome

Missed primary endpoint

paper Median progression-free survival was not different between arms PMID 31115844 ↗

paper CONCLUSION: Although well tolerated, the efficacy of everolimus and vinorelbine combination therapy was not superior to vinorelbine monotherapy. PMID 31115844 ↗

Publications

• Decker T, Marschner N, Muendlein A, Welt A, Hagen V, Rauh J, Schroder H, Jaehnig P, Potthoff K, Lerchenmuller C. VicTORia: a randomised phase II study to compare vinorelbine in combination with the mTOR inhibitor everolimus versus vinorelbine monotherapy for second-line chemotherapy in advanced HER2-negative breast cancer. Breast Cancer Res Treat. 2019 Aug;176(3):637-647. doi: 10.1007/s10549-019-05280-2. Epub 2019 May 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	5 mg	Oral
Subject	Vinorelbine	Small molecule	25 mg/m2	Intravenous

Indications