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A Study Evaluating the Efficacy and Safety of Lapatinib + Vinorelbine in ErbB2 Positive Metastatic Breast Cancer Patients

NCT01161368 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2015-08-13

No results posted yet for this study

Summary

The objective of this phase II study is to gain first information on the efficacy (PFS, ORR and OS) and safety of lapatinib plus vinorelbine in patients with HER2 positive metastatic breast cancer pretreated with a combination therapy (chemotherapy and/or hormonal therapy) including lapatinib and presenting with tumor progression.

Primary objective is to assess the efficacy with respect to the percentage of patients surviving without disease progression as assessed by RECIST criteria.

Secondary objectives are to assess the efficacy of the study treatment with respect to the objective response rates as assessed by RECIST criteria version 1.1, the overall survival and to evaluate the safety profile of the combination by recording the adverse events and abnormal laboratory values associated with the study treatments.

The main efficacy endpoints will be investigated both for the intent-to-treat (ITT) population and the per-protocol (PP) population.

Conditions

Interventions

DRUG

Lapatinib, Vinorelbine

Lapatinib 1250mg orally once daily continuously plus Vinorelbine 20 mg/m2 intravenously (IV) once weekly \[Days 1 and 8\] for 2 weeks, followed by a rest week in a 3-week cycle.

Sponsors & Collaborators

  • Central European Cooperative Oncology Group

    lead OTHER

Principal Investigators

  • Istvan Lang, MD · National Institute of Oncology Rath Gyorgy u. 7-9. 1122 Budapest

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Austria
  • Hungary

Study Locations

More Related Trials

Entities

Diseases

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 NCT01161368 on ClinicalTrials.gov