NCT02973737

A Study of Pyrotinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer

Pyrotinib Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer:a Randomised, Double-blind, Multicentre, Phase 3 Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 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, multi-center, multinational, double blind, active-controlled, parallel design study of the combination of pyrotinib in combination with capecitabine versus placebo plus capecitabine in HER2+ MBC patients, who have prior received anthracyclin, taxane and trastuzumab. Patients will be randomized in a 2:1 ratio to one of the following treatment arms: Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m\^2 twice daily) Arm B: placebo (400 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. Patients in control group can be provide pyrotinib treatment when they progressed after the placebo plus capecitabine treatment.

Detailed description

This study is a phase 3, randomized, multi-center, multinational, double blind, active-controlled, parallel design study of the combination of pyrotinib in combination with capecitabine versus placebo plus capecitabine in HER2+ MBC patients, who have prior received anthracyclin, taxane and trastuzumab. Patients will be randomized in a 2:1 ratio to one of the following treatment arms: Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m\^2 twice daily) Arm B: placebo (400 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. Efficacy assessments will be performed at screening, every 6 weeks until cycle 18, every 12 weeks thereafter. Patients in control group can be provide pyrotinib treatment when they progressed after the placebo plus capecitabine treatment. Pyrotinb will be administrated until the patients reached progress again or wit

Conditions

• HER2 Positive Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	pyrotinib	400 mg once daily
DRUG	placebo	400 mg once daily
DRUG	Capecitabine	1000 mg/m2 per day on day 1 through 14, every 21 days.

Timeline

• Start date: 2016-07-20
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2016-11-25
• Last updated: 2022-10-25

Locations

1 site across 1 country: China