Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT04681911
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Inetetamab — DRUG
    Inetetamab: 8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle.
  • Pyrotinib — DRUG
    Pyrotinib: 400mg, oral, every day.
  • Capecitabine — DRUG
    Capecitabine, 1000 mg/m2, d1-d14, 3-week cycle
  • Gemcitabine — DRUG
    Gemcitabine, 1000 mg/m2, D1, D8, 3-week cycle
  • Vinorelbine — DRUG
    Vinorelbine, 25-30 mg/m2, D1, D8, 3-week cycle
  • Carboplatin — DRUG
    Carboplatin, AUC = 6, 3-week cycle
  • Albumin paclitaxel — DRUG
    Albumin paclitaxel, 100 mg/m2, weekly
  • Eribulin — DRUG
    Eribulin, 1.4 mg/m2, D1, D8, 3-week cycle

Study Details

HER2-targeted therapy after the failure of trastuzumab treatment has become a new difficulty and challenge. Inetetamab, a new antibody to optimize the ADCC effect, has become one of the second-line treatment options after trastuzumab fails, showing good survival benefits. Pyrotinib, another second-line HER2 targeted drug, is a typical representative of TKI drugs, which not only has a strong HER2 antagonistic effect but also can synergize with monoclonal antibodies to amplify the ADCC effect. Pyrotinib and Inetetamab showed excellent anti-tumor efficacy and good safety in TKI and optimized ADCC respectively. we plan to carry out a phase II single-arm clinical study to evaluate the efficacy and safety of "Inetetamab combined with Pyrotinib and chemotherapy" in the treatment of her positive metastatic breast cancer.

Key Dates

Start date
Sep 9, 2020
Status verified
Dec 2020
Primary completion
Sep 9, 2023
Completion
Sep 9, 2024

Study Design

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

Arms

  • Experimental: Inetetamab Combined With Pyrotinib and Chemotherapy
    Inetetamab: 8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle. Pyrotinib: 400mg, oral, every day. Chemotherapy: the choice of physicians，as the following regimens: Capecitabine, 1000 mg/m2, d1-d14, 3-week cycle Gemcitabine, 1000 mg/m2, D1, D8, 3-week cycle Vinorelbine, 25-30 mg/m2, D1, D8, 3-week cycle Carboplatin, AUC = 6, 3-week cycle Albumin paclitaxel, 100 mg/m2, weekly Eribulin, 1.4 mg/m2, D1, D8, 3-week cycle

Primary Outcome Measure

Objective Response Rate，ORR [ Time Frame: 18 weeks after enrollment ]

Central Contacts

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