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A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

NCT01808573 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 621

Last updated 2021-06-11

Study results available
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Summary

This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.

Conditions

  • HER2+ Metastatic Breast Cancer (MBC)

Interventions

DRUG

neratinib

DRUG

capecitabine

DRUG

lapatinib

Sponsors & Collaborators

  • Puma Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Senior Vice President Clinical Science and Pharmacology · Puma Biotechnology, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-29
Primary Completion
2018-09-28
Completion
2019-12-09
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hong Kong
  • Ireland
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Portugal
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT01808573 on ClinicalTrials.gov