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Vinorebine, Everolimus

Phase 2

Her2-negative Metastatic Breast Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Aug 9, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment139

FDA Designations

No designations recorded

Clinical trial landscape

Vinorebine, Everolimus · 1 trial · 2 indications

Phase 2 1
NCT01520103Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced Breast CancerHer2-negative Metastatic Breast Cancer
COMPLETED139 Analytics
PHASE2COMPLETED
Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced Breast Cancer
Her2-negative Metastatic Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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.

Secondary Endpoints

Safety and tolerability
Assessment over 36 months
Rate of Progression Free Survival after 6 months (6 months PFSR)
Assessment over 36 months
Overall survival (OS)
36 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Vinorelbin and EverolimusEXPERIMENTAL -
standard therapyOTHERVinorelbin

Interventions

NameTypeDescription
Vinorebine, EverolimusDRUGVinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw Everolimus: oral 5 mg/d d1-21 3qw until progress
VinorelbineDRUGVinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw until progress
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

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...

Countries:Germany
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Frequently asked questions about Vinorebine, Everolimus

What is Vinorelbine, Everolimus used for?

Vinorelbine, Everolimus is a combination of two small molecules being studied for the treatment of HER2-negative metastatic breast cancer and HER2-negative locally advanced breast cancer. It is currently in Phase 2 clinical development and is being investigated as a second-line treatment for advanced breast cancer.

What does Vinorelbine, Everolimus target?

The combination includes everolimus, an mTOR inhibitor, and vinorelbine, a chemotherapy agent. Everolimus targets mTOR, a protein involved in cell growth and proliferation, while vinorelbine disrupts microtubule dynamics to inhibit cancer cell division. The combination is being studied in biomarker-selected patients.

Who makes Vinorelbine, Everolimus?

Vinorelbine, Everolimus is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical trials to evaluate this combination therapy for the treatment of HER2-negative metastatic and locally advanced breast cancer.

What phase is Vinorelbine, Everolimus in?

Vinorelbine, Everolimus is in Phase 2 clinical development. It is an investigational combination therapy and has not been approved by regulatory authorities. One Phase 2 trial has been completed, involving 139 female participants aged 18 years and older.

What clinical trials is Vinorelbine, Everolimus in?

Vinorelbine, Everolimus has one completed clinical trial, NCT01520103, which compared vinorelbine combined with the mTOR inhibitor everolimus versus vinorelbine monotherapy as second-line treatment in advanced breast cancer. The trial was conducted in Germany and enrolled 139 patients.

Is Vinorelbine, Everolimus the same as everolimus alone?

No, Vinorelbine, Everolimus is a combination of two drugs: vinorelbine and everolimus. Everolimus alone is an mTOR inhibitor, while vinorelbine is a chemotherapy agent. The combination is being studied to determine if adding everolimus to vinorelbine improves outcomes in HER2-negative advanced breast cancer.