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

NCT01520103 Phase 2 COMPLETED

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.

Details

Lead sponsor	AIO-Studien-gGmbH
Phase	Phase 2
Status	COMPLETED
Enrolment	139
Start date	2012-01
Completion	2016-10-31

Conditions

• Her2-negative Metastatic Breast Cancer
• Her2-negative Locally Advanced Breast Cancer

Interventions

• Vinorebine, Everolimus
• Vinorelbine

Primary outcomes

• Progression-free survival (PFS) — Assessment over 36 months, minimum 12 month
  Progression-free survival (PFS) will be defined as the time from randomization to the time of disease progression or relapse or death.

Countries

Germany