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Neoadjuvant Inetetamab Combined With Pertuzumab and Paclitaxel/Carboplatin for Breast Cancer

NCT05749016 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-03-01

No results posted yet for this study

Summary

Inetetamab (Cipterbin) is a newly marketed anti-HER2 monoclonal antibody with amino acid modified Fc region and enhanced antibody-dependent cellular cytotoxicity (ADCC) effect. There was no robust evidence evaluating the combination of inetetamab with pertuzumab and neoadjuvant chemotherapy (paclitaxel + carboplatin) in the neoadjuvant setting. This study aimed to evaluate the efficacy and safety of inetetamab + pertuzumab+paclitaxel + carboplatin (TCbIP) as a neoadjuvant chemotherapy regimen in the treatment of patients with locally advanced HER2-positive breast cancer.

Conditions

  • Locally Advanced Breast Cancer
  • Chemotherapy Effect

Interventions

DRUG

inetetamab with pertuzumab and paclitaxel/carboplatin (TCbIP) regimen

Inetetamab (Cipterbin) is a newly marketed anti-HER2 monoclonal antibody with amino acid modified Fc region and enhanced antibody-dependent cellular cytotoxicity (ADCC) effect. There was no robust evidence evaluating the combination of inetetamab with pertuzumab and neoadjuvant chemotherapy (paclitaxel + carboplatin) in the neoadjuvant setting. This study aimed to evaluate the efficacy and safety of inetetamab + pertuzumab+paclitaxel + carboplatin (TCbIP) as a neoadjuvant chemotherapy regimen in the treatment of patients with locally advanced HER2-positive breast cancer.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Binghe Xu, Dr. · National Cancer Center/National Clinical Research Center for Cancer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-07-01
Completion
2023-12-01

Countries

  • China

Study Locations

More Related Trials

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 NCT05749016 on ClinicalTrials.gov