A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer

Sponsor
Chinese Academy of Medical Sciences
Study ID
NCT03933982
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pyrotinib Plus Vinorelbine — DRUG
    Pyrotinib: 320mg/d, q.d., p.o. A course of treatment need 21 days. Vinorelbine: 60mg/m2 q.d. d1,8,15, p.o. A course of treatment need 21 day.

Study Details

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, open label clinical study of pyrotinib plus vinorelbine as the therapy of brain metastases from HER2-positive metastatic breast cancer.

Key Dates

Start date
Dec 22, 2018
Status verified
May 2019
Primary completion
Dec 22, 2021
Completion
Jun 22, 2022

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pyrotinib plus Vinorelbine

Primary Outcome Measure

Objective Response Rate (ORR) of CNS [ Time Frame: Estimated up to 1 year ]

Central Contacts

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