A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab

Conditions

• HER2 Positive Metastatic Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• pyrotinib — DRUG
• Lapatinib — DRUG
• capecitabine — DRUG

Study Details

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of pyrotinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have prior received anthracyclin, taxane or trastuzumab. Patients will be stratified by weather have prior use of trastuzumab and randomized in a 1:1 ratio to one of the following treatment arms: * Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m\^2 twice daily) * Arm B: lapatinib (1250 mg once daily) + capecitabine (1000 mg/m\^2 twice daily) Patients will receive either arm of therapy until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.

Key Dates

Start date

May 31, 2015

Status verified

Jul 2018

Primary completion

Oct 31, 2016

Completion

Dec 31, 2018

Study Design

Enrollment

128 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: pyrotinib plus capecitabine
  pyrotinib(400 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)
• Active Comparator: lapatinib plus capecitabine
  lapatinib (1250 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)

Primary Outcome Measure

Safety(adverse Events [AEs] and Serious Adverse Events [SAEs]) [ Time Frame: : From consent through 28 days following treatment completion (estimated 18 months) ]