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

NCT01520103 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2017-08-09

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Vinorebine, Everolimus

Vinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw Everolimus: oral 5 mg/d d1-21 3qw until progress

DRUG

Vinorelbine

Vinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw until progress

Sponsors & Collaborators

Principal Investigators

  • Christian Lerchenmüller, Dr. · Hämatologisch-onkologische Gemeinschaftspraxis, Münster

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01520103 on ClinicalTrials.gov