Pyrotinib Maleate Combined With Vinorelbine in the Treatment of HER2-positive Advanced Breast Cancer

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT04903652
Phase
PHASE2
Status
Completed

Conditions

  • HER2-positive Advanced Breast Cancer

Eligibility Criteria

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

Interventions

  • Pyrotinib Maleate — DRUG
    Pyrotinib p.o. 400 mg once daily
  • Vinorelbine — DRUG
    Vinorelbine p.o. 40 mg once every other day

Study Details

This study is a single-center, single-arm, prospective phase II clinical study, which mainly evaluates the efficacy and safety of pyrotinib maleate combined with oral vinorelbine in the treatment of HER2-positive advanced breast cancer.

Key Dates

Start date
Jan 1, 2021
Status verified
Jan 2022
Primary completion
Feb 1, 2022
Completion
Feb 6, 2022

Study Design

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

Arms

  • Experimental: Pyrotinib plus Vinorelbine

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Estimated 24 months ]

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