Objectives: This phase III placebo-controlled trial asks whether adding mTOR inhibition with everolimus (Afinitor) to vinorelbine and trastuzumab can improve progression-free survival; overall survival is a secondary outcome measure.
Key entry or exclusionary criteria: Patients must have HER2-positive breast cancer that is inoperable locally recurrent or metastatic disease. No prior treatment with mTOR inhibitors or vinca alkaloid allowed.
Locations: 182 sites.
Goal: 572 patients.
Study sponsor: Novartis Pharmaceuticals
Link for more information: clinicaltrials.gov/ct2/show/NCT01007942
NIH clinical trials identifier: NCT01007942