Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced Breast Cancer
- Sponsor
- AIO-Studien-gGmbH
- Study ID
- NCT01520103
- Phase
- PHASE2
- Status
- Completed
Conditions
- Her2-negative Locally Advanced Breast Cancer
- Her2-negative Metastatic Breast Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Vinorebine, Everolimus — DRUGVinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw Everolimus: oral 5 mg/d d1-21 3qw until progress
- Vinorelbine — DRUGVinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw until progress
Study Details
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.
Key Dates
- Start date
- Jan 31, 2012
- Status verified
- Aug 2017
- Primary completion
- Oct 31, 2016
- Completion
- Oct 31, 2016
Study Design
- Enrollment
- 139 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Vinorelbin and Everolimus
- Other: standard therapyVinorelbin
Primary Outcome Measure
Progression-free survival (PFS) [ Time Frame: Assessment over 36 months, minimum 12 month ]