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

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 t...
Source: Cancer Research - Category: Cancer & Oncology Authors: Tags: Ongoing Clinical Trials Source Type: research