Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced Breast Cancer (VicTORia)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01520103|
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : August 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Her2-negative Metastatic Breast Cancer Her2-negative Locally Advanced Breast Cancer||Drug: Vinorebine, Everolimus Drug: Vinorelbine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||January 2012|
|Primary Completion Date :||October 31, 2016|
|Study Completion Date :||October 31, 2016|
|Experimental: Vinorelbin and Everolimus||
Drug: Vinorebine, Everolimus
Vinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw Everolimus: oral 5 mg/d d1-21 3qw until progress
Vinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw until progress
- Progression-free survival (PFS) [ Time Frame: 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.
- Safety and tolerability [ Time Frame: Assessment over 36 months ]
Capture all adverse events, serious adverse events, all side effects of the study medication, serious side effects, adverse events that lead to temporary or complete discontinuation of the study treatment and the Rates and causes of death.
A safety interims analysis is planned, as soon as 60 subjects have finished at least two treatment cycles.
- Rate of Progression Free Survival after 6 months (6 months PFSR) [ Time Frame: Assessment over 36 months ]descriptive Evaluation, for the monotherapy (arm 2) a median PFS of 4 months is assumed. It is expected that the combination therapy will prolong the median PFS to 6.5 months.
- Overall survival (OS) [ Time Frame: 36 months ]The duration of overall survival (OS) will be determined by measuring the time interval from randomization to the date of death or last observation.
- Response rate (CR, PR) [ Time Frame: 36 months ]The tumour status of patients will be evaluated nine weekly during the treatment until detection of progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520103
|Hämatologisch-onkologische Gemeinschaftspraxis, Münster|
|Münster, Germany, 48149|
|Principal Investigator:||Christian Lerchenmüller, Dr.||Hämatologisch-onkologische Gemeinschaftspraxis, Münster|