Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01520103 | Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced Breast Cancer | PHASE2 | COMPLETED | 139 | — | — | Jan 1, 2012 | Oct 31, 2016 | Aug 9, 2017 | 1 | Germany |
Progression-free survival (PFS) will be defined as the time from randomization to the time of disease progression or relapse or death.
| Arm | Type | Description |
|---|---|---|
| Vinorelbin and Everolimus | EXPERIMENTAL | - |
| standard therapy | OTHER | Vinorelbin |
| Name | Type | Description |
|---|---|---|
| Vinorebine, Everolimus | DRUG | Vinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw Everolimus: oral 5 mg/d d1-21 3qw until progress |
| Vinorelbine | DRUG | Vinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw until progress |
Inclusion Criteria: 1 .Dated and signed patient informed consent before start of any in the protocol specified procedures 2. Histologically or cytologically confirmed Her2/neu negative, metastatic or locally advanced breast cancer, including inoperable local relapse, with measurable or non-measurab...