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

Phase 1

• Conditions: HER2 Positive Metastatic Breast Cancer
• Interventions: Drug: Lapatinib; Drug: pyrotinib; Drug: capecitabine

• Registration Number: NCT02422199
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-21
• Study Start: 2015-05
• Primary Completion: 2016-10
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-05
• Last Update Posted: 2018-07-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pyrotinib plus capecitabine	capecitabine	pyrotinib(400 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)
lapatinib plus capecitabine	capecitabine	lapatinib (1250 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)
lapatinib plus capecitabine	Lapatinib	lapatinib (1250 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)
pyrotinib plus capecitabine	pyrotinib	pyrotinib(400 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)

Primary Outcome Measures

Name	Time	Method
Safety(adverse Events [AEs] and Serious Adverse Events [SAEs])	: From consent through 28 days following treatment completion (estimated 18 months)
Objective Response Rate (ORR)	Estimated 12 months

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Estimated 18 months
Time to Progression (TTP)	Estimated 18 months
Duration of Response (DOR)	Estimated 18 months

Trial Locations

Locations (2)

307 Hospital Affiliated to Academy Military Medical Science; 🇨🇳 Beijing, China

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China