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Safety and Efficacy of Lapatinib Plus Trastuzumab or Lapatinib Plus Capecitabine in Metastatic Breast Cancer

NCT01985893 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-01-14

No results posted yet for this study

Summary

The purpose of this study is to estimate the clinical benefit of lapatinib plus trastuzumab compared to lapatinib plus capecitabine as measured by investigator-assessed progression-free survival, tumour response and overall survival.

Conditions

Interventions

DRUG

Lapatinib plus trastuzumab

Comparison of the safety and efficacy of lapatinib plus trastuzumab and lapatinib plus capecitabine.

Sponsors & Collaborators

  • OnkoDataMed GmbH

    collaborator INDUSTRY

  • Berufsverband Niedergelassener Gynäkologischer Onkologen in Deutschland e.V.

    lead OTHER

Principal Investigators

  • Dirk Elling, Professor · Frauenklinik, Sana Klinikum Lichtenberg, Fanningerstr. 32, D-10365 Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Germany

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 NCT01985893 on ClinicalTrials.gov