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

Conditions

• HER2 Positive Metastatic Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

May 3, 2017

Status verified

Jun 2020

Primary completion

Mar 31, 2019

Completion

Mar 31, 2021

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pyrotinib Plus Capecitabine
• Active Comparator: Lapatinib Plus Capecitabine

Primary Outcome Measure

Progression Free Survival(PFS) [ Time Frame: Estimated 10 months ]