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HB1801 Combined Treatment of HER2-positive Breast Cancer

NCT07116824 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-08-12

No results posted yet for this study

Summary

This study is designed to evaluate the safety and efficacy of HB1801 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic breast cancer.

Conditions

Interventions

DRUG

HB1801

HB1801 is administered by intravenous infusion.

DRUG

Trastuzumab

Trastuzumab is administered by intravenous infusion, 8mg/kg loading dose and then 6mg/kg per cycle, Q3W.

DRUG

Pertuzumab

Pertuzumab is administered by intravenous infusion, 840mg loading dose and then 420mg per cycle, Q3W.

DRUG

Docetaxel

Docetaxel is administered by intravenous infusion, 75mg/m\^2, Q3W.

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-07-15
Completion
2027-11-07

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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 NCT07116824 on ClinicalTrials.gov