Pyrotinib and Vinorelbine Tartrate Capsules With or Without Inetetamab for First Line Treatment in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer

Sponsor
Zhiyong Yu
Study ID
NCT04963595
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Pyrotinib — DRUG
    400 mg once daily
  • Vinorelbine — DRUG
    Initial dose 70 mg/m2 on days 1 and 8 (capsules) If well tolerated, subsequently 90 mg/m2 on days 1 and 8. Capsules on day 1 to be taken at the hospital, and on day 8 at home.
  • Inetetamab — DRUG
    8mg/kg iv day 1 followed by 6mg/kg iv day 1, cycled every 21 days

Study Details

Trastuzumab resistance, which is a common therapeutic challenge in HER2 positive metastatic breast cancer, is not fully understood. Pyrotinib is an oral tyrosine kinase inhibitor targeting EGFR, HER-2 and HER-4 receptors. More general inhibition of ErbB family with pyrotinib could provide additional benefit. Inetetamab could bind to HER2 extracellular domain (ECD) with high affinity and inhibit proliferation of multiple HER2-overexpressing cancer cell lines as a single agent or in combination with trastuzumab. This study is designed to evaluate the efficacy and safety of pyrotinib and vinorelbine tartrate capsulesin with or without Inetetamab for first line treatment in patients with HER2 positive metastatic breast cancer who had early failure on or after trastuzumab treatment.

Key Dates

Start date
Aug 1, 2021
Status verified
Jul 2021
Primary completion
Jan 31, 2023
Completion
Jul 31, 2024

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pyrotinib and Vinorelbine with Inetetamab
  • Experimental: Pyrotinib and Vinorelbine without Inetetamab

Primary Outcome Measure

PFS [ Time Frame: 6 weeks ]

Central Contacts

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