Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of HER2-positive Metastatic Breast Cancer

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT05823623
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Inetetamab — DRUG
    Patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment.
  • Pyrotinib — DRUG
    Patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment.
  • Oral Vinorelbine Tartrate — DRUG
    Patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment.

Study Details

In this phase 2 single-arm clinical trial, 30 patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment of Inetetamab plus Pyrotinib plus Oral Vinorelbine. The study aimed to access the efficacy and safety of Inetetamab combined with Pyrotinib and Oral Vinorelbine in HER2-positive metastatic breast cancer patients after progression on trastuzumab.

Key Dates

Start date
Feb 13, 2022
Status verified
Sep 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: Inetetamab combined with Pyrotinib plus Oral Vinorelbine
    Inetetamab: 8mg/kg for the first dose, 6mg/kg for the following doses, intravenous, every 3 weeks for one cycle. Pyrotinib: 400mg, oral, every day. Vinorelbine: 60mg/m2, oral, every week.

Primary Outcome Measure

Progression Free Survival，PFS [ Time Frame: 2 years ]

Central Contacts

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