Inetetamab Combined With Pyrotinib and Vinorelbine as First-line to Third-line Treatment for HER2-positive Metastatic Breast Cancer

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT05764941
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Inetetamab — DRUG
    8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle.
  • Pyrotinib — DRUG
    400mg, oral, every day.
  • Vinorelbine — DRUG
    25 mg/m2, D1, D8, every 3 weeks for one cycle.

Study Details

This is a real world study to evaluate the efficacy and safety of inetetamb combined with pyrotinib and vinorelbine as first-line to third-line treatment after trastuzumab progression in HER2-positive metastatic breast cancer.

Key Dates

Start date
Jan 1, 2020
Status verified
Mar 2023
Primary completion
Mar 1, 2024
Completion
Mar 31, 2024

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Observational Group
    Patients receive initetamab combined with pyrotinib and vinorelbine after trastuzumab progression.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 2 years ]

Central Contacts

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