A Multicenter, Randomized, Double-Blind, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 in Combination With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy in Locally Advanced Unresectable and/or Metastatic HER2-Positive Breast Cancer Previously Treated With HER2 ADC

Shanghai Henlius Biotech0 个研究点目标入组 90 人开始时间: 2026年10月31日最近更新: 2026年9月17日

适应症

干预措施

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 90
主要终点: Objective response rate (ORR) assessed by the blinded independent central review (BICR) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is a phase II study of HLX22 in combination with trastuzumab and chemotherapy versus placebo in combination with trastuzumab and chemotherapy in locally advanced and/or metastatic HER2-Positive breast cancer previously treated with HER2 ADC. Eligible participants will be treated with the study drug until the loss of clinical benefit, intolerable toxicity, initiation of new anti-tumor therapy, voluntary withdrawal from the study by the patient, loss to follow-up, death, or when the investigator determines that the patient should be withdrawn from the study (whichever occurs first).

详细描述

Experimental group: HLX22 + trastuzumab + investigator's choice of chemotherapy, once every 3 weeks (Q3W).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Aged ≥ 18 years (or the legal age of adulthood per country-specific regulation) at the time of signing the ICF, male or female.
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or - Life expectancy of ≥ 6 months.
•Histologically confirmed breast cancer with radiologically or otherwise documented locally advanced unresectable and/or metastatic disease.
•HER2 positive confirmed by central laboratory.
•Hormone receptor (HR) status confirmed by local laboratory.
•Patients who have progressed after treatment containing within HER2 ADC
•Presence of at least one measurable lesion according to the RECIST v1.
•Adequate organ function

排除标准

•History of any other malignancy within 2 years prior to signing the ICF.
•Prior use of doxorubicin with a cumulative in vivo dose of > 360 mg/m
•Adverse events from prior anti-tumor treatment that have not resolved to Grade ≤ 1 or baseline level according to CTCAE v6.
•Uncontrolled or severe cardiovascular disease.
•History of cerebrovascular accident within 6 months prior to randomization.
•Current (non-infectious) interstitial lung disease (ILD)/pneumonia that requires steroid treatment.
•Active infection.
•Active tuberculosis.
•Presence of spinal cord compression or clinically symptomatic central nervous system metastases.
•Receipt of systemic anti-tumor treatment and immunotherapy, within 4 weeks prior to randomization
•Pregnant or lactating women or women who plan to become pregnant during the study period.
•History of immunodeficiency or history of organ transplantation.

研究组 & 干预措施

Control group

Placebo Comparator

placebo + trastuzumab + investigator's choice of chemotherapy (capecitabine or paclitaxel or docetaxel or eribulin or vinorelbine)

干预措施: Eribulin (Drug)

Control group

Placebo Comparator

placebo + trastuzumab + investigator's choice of chemotherapy (capecitabine or paclitaxel or docetaxel or eribulin or vinorelbine)

干预措施: Trastuzumab (Drug)

Control group

Placebo Comparator

placebo + trastuzumab + investigator's choice of chemotherapy (capecitabine or paclitaxel or docetaxel or eribulin or vinorelbine)

干预措施: Docetaxel (Drug)

Control group

Placebo Comparator

placebo + trastuzumab + investigator's choice of chemotherapy (capecitabine or paclitaxel or docetaxel or eribulin or vinorelbine)

干预措施: Capecitabine (Drug)