Abstract OT1-04-07: VICTORIANE: A randomized phase 3 study assessing the addition of oral vinorelbine to aromatase inhibitors for the treatment of patients with metastatic breast cancer
Authors: Villanueva CB , Barthelemy P , Ferrero JM , Jacquin JP , Bonnetain F , Mansi L , Pivot X 
Published: March 2017

Abstract
Background : The addition of anti-proliferative agents such new inhibitors of CDK4/6 to hormonotherapy have significantly improved the efficacy in patients with metastatic breast cancer (MBC). Oral vinorelbine provided the opportunity to give new schedules of chemotherapy with favourable tolerability and prolonged exposure. The present trial was designed to evaluate the clinical effects of the addition of oral vinorelbine to aromatase inhibitors in first line treatment for MBC.
Methods : In this phase III, randomized, prospective, open trial named VICTORIANE (NCT02730091), postmenopausal women with HR+/HER2– with MBC are randomized (1:1) between letrozole or anastrozole once a day (Arm A) versus oral vinorelbine 50 mg three times a every week with letrozole or anastrozole (Arm B). Continuous daily schedule (days 1-28 of each 28 days cycle) is planned until disease progression or discontinuation for other reasons. A minimisation algorithm was used stratifying treatment allocation according to the existence of visceral metastases, prior adjuvant hormonal treatment and centers. The study is conducted in compliance with the principles of good clinical practice and the declaration of Helsinki.
Key inclusion criteria include, histologicaly proven HER2-negative and Estrogen Receptor-positive breast cancer, metastatic setting, no prior systemic anti-cancer therapy for MBC, recurrence after prior hormonal therapy in the adjuvant setting is allowed if disease free interval is greater than 24 months from the completion of treatment, normal liver, bone marrow and renal functions, Performans status greater than 2. Non inclusion criteria include symptomatic visceral disease, or disease burden precluding endocrine therapy, and prior therapy with vinorelbine.
The primary endpoints is progression-free survival (PFS; local assessment, RECIST v1.1) and secondaries endpoints are overall survival, health-related quality of life, overall response rate and safety. Analysis of the primary endpoint will be performed with a stratified log-rank test (95% confidence interval). A 30 percent reduction in the risk of events (Hazard Ratio (HR) = 0.70) was assumed under H1 in the arm B. This reduction was estimated based on an absolute gain of 3.857 months in terms of median PFS, from 9 months (arm A) to 12.857 months (arm B). Global recruitment of the planned 340 pts is ongoing and should be completed in march 2018. Final results will be expected in 2019.
Citation Format: Villanueva CB, Barthelemy P, Ferrero JM, Jacquin JP, Bonnetain F, Mansi L, Pivot X. VICTORIANE: A randomized phase 3 study assessing the addition of oral vinorelbine to aromatase inhibitors for the treatment of patients with metastatic breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT1-04-07.