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

HER2 Positive Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02422199
• Other study ID #: HR-BLTN-I/II-MBC
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: May 2015
• Est. completion date: December 2018

Study information

• Verified date: July 2018
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: December 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Aged =18 and =70 years.

• ECOG performance status of 0 to 1.

• Life expectancy of more than 12 weeks.

• At least one measurable lesion exists.(RECIST 1.1).

• Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies.

• Required laboratory values including following parameters:

ANC: = 1.5 x 10^9/L;Platelet count: = 100 x 10^9/L;Hemoglobin: = 9.0 g/dL;Total bilirubin:

= 1.5 x upper limit of normal (ULN);ALT and AST: = 1.5 x ULN;BUN and creatine clearance rate: = 50 mL/min;LVEF: = 50%;QTcF: < 470 ms for female and < 450 ms for male.

• Signed informed consent

Exclusion Criteria:

• Received previous therapy with lapatinib, neratinib, pyrotinib or any other HER2 directe tyrosine kinase inhibitor.

• Received previous therapy with capecitabine within 3 months.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2 Positive Metastatic Breast Cancer

Intervention

Drug:
• pyrotinib

• Lapatinib

• capecitabine

Locations

Country	Name	City	State
China	307 Hospital Affiliated to Academy Military Medical Science	Beijing
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety(adverse Events [AEs] and Serious Adverse Events [SAEs])		: From consent through 28 days following treatment completion (estimated 18 months)
Primary	Objective Response Rate (ORR)		Estimated 12 months
Secondary	Progression Free Survival (PFS)		Estimated 18 months
Secondary	Time to Progression (TTP)		Estimated 18 months
Secondary	Duration of Response (DOR)		Estimated 18 months