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Efficacy and Safety of Pyrotinib Maleate Combined With ARX788 Neoadjuvant Treatment in Breast Cancer Patients

NCT04983121 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-09-13

No results posted yet for this study

Summary

Next-generation Site-specific human epidermal growth factor receptor 2 (HER2)-targeting Antibody-drug Conjugate (ARX788) is an antibody-conjugated drug. Results from the phase I safety, tolerability and pharmacokinetic trial of ARX788 single drug in Chinese patients with advanced HER2 breast cancer indicated a good safety of the test drug, and responses to anti-tumor therapy were observed in the target dose group. Phase II clinical trial is being carried out gradually. This trial is designed to observe the effectiveness and safety of pyrotinib maleate combined with ARX788 neoadjuvant treatment in stage II-III HER2-positive breast cancer patients experiencing a poor efficacy of trastuzumab and pertuzumab.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Next-generation Site-specific human epidermal growth factor receptor 2 (HER2)-targeting Antibody-drug Conjugate (ARX788)

The subjects who sign an informed consent will enter the treatment period after screening. Each eligible subject will receive pyrotinib, 320 mg once a day, with 21 days as a session, for 6 sessions in total before operation. Next-generation Site-specific human epidermal growth factor receptor 2 (HER2)-targeting Antibody-drug Conjugate (ARX788) will be intravenously injected at a dose of 1.5 mg/kg, once every 3 weeks, with 21 days as a session, for 6 sessions before surgery. Breast MRI and other imaging examinations will be reviewed every 2 sessions to evaluate the curative effect, and the patient's baseline will be defined based on the imaging report at the time of enrollment. If a definite effect (complete response/partial response) is achieved, surgical treatment will be performed within 4 weeks (\> 2 weeks) after completion of 6 sessions of neoadjuvant therapy.

Sponsors & Collaborators

  • Shengjing Hospital

    lead OTHER

Principal Investigators

  • Cai-Gang Liu · Department of Breast Surgery, Shengjing Hospital affiliated to China Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2027-08-15
Completion
2027-08-15

Countries

  • China

Study Locations

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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 NCT04983121 on ClinicalTrials.gov