NCT03080805

Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer. (PHOEBE)

A Randomised, Open-label, Parallel Controlled, Multicentre, Phase 3 Clinical Trial of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer:

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized,open-label,multi-center,active-controlled, parallel design study of the combination of pyrotinib and capecitabine versus Lapatinib plus capecitabine in HER2+ MBC patients, who have prior received taxane and trastuzumab.Patients will be 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 disease progression, unacceptable toxicity, or withdrawalof consent.

Conditions

• HER2 Positive Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib Plus Capecitabine	pyrotinib(400 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/ m\^2 BID)
DRUG	Lapatinib Plus Capecitabine	Lapatinib (1250 mg once daily)+ capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)

Timeline

• Start date: 2017-05-03
• Primary completion: 2019-03-31
• Completion: 2021-03-01
• First posted: 2017-03-15
• Last updated: 2020-06-18

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study