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

NCT04681911 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2020-12-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Inetetamab

Inetetamab: 8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle.

DRUG

Pyrotinib

Pyrotinib: 400mg, oral, every day.

DRUG

Capecitabine

Capecitabine, 1000 mg/m2, d1-d14, 3-week cycle

DRUG

Gemcitabine

Gemcitabine, 1000 mg/m2, D1, D8, 3-week cycle

DRUG

Vinorelbine

Vinorelbine, 25-30 mg/m2, D1, D8, 3-week cycle

DRUG

Carboplatin

Carboplatin, AUC = 6, 3-week cycle

DRUG

Albumin paclitaxel

Albumin paclitaxel, 100 mg/m2, weekly

DRUG

Eribulin

Eribulin, 1.4 mg/m2, D1, D8, 3-week cycle

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Jianli Zhao · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2023-09-09
Completion
2024-09-09

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04681911 on ClinicalTrials.gov