This trial is active, not recruiting.

Condition her2 positive metastatic breast cancer
Treatments pyrotinib, lapatinib, capecitabine
Phase phase 1/phase 2
Sponsor Jiangsu HengRui Medicine Co., Ltd.
Start date May 2015
End date October 2016
Trial size 128 participants
Trial identifier NCT02422199, HR-BLTN-I/II-MBC


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
pyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)
(Active Comparator)
lapatinib (1250 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)

Primary Outcomes

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

Secondary Outcomes

Progression Free Survival (PFS)
time frame: Estimated 18 months
Time to Progression (TTP)
time frame: Estimated 18 months
Duration of Response (DOR)
time frame: Estimated 18 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd..