Recruiting

A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer

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What is being tested

SHR-A1811

+ Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel

Drug
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

From 18 to 75 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2023
See protocol details

Summary

Principal SponsorJiangsu HengRui Medicine Co., Ltd.
Study ContactShouwei ZhaoMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 30, 2023

Actual date on which the first participant was enrolled.

The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.

Official TitleA Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer
NCT05814354
Principal SponsorJiangsu HengRui Medicine Co., Ltd.
Study ContactShouwei ZhaoMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

530 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

7 inclusion criteria required to participate
Low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested).
HR-positive breast cancer with at least one endocrine therapy and disease progression was judged by the investigator to no longer benefit from endocrine therapy.
Has been treated with 0 to 1 prior lines of chemotherapy in the metastatic setting.
Has documented radiologic progression (during or after most recent treatment).
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6 exclusion criteria prevent from participating
Has known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable.
A history of human immunodeficiency virus (HIV) infection is known, or has an active autoimmune disease.
History of interstitial lung disease or pneumonia requiring oral or intravenous steroids.
Has moderate or severe cardiovascular disease.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator
Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, ChinaOpen Cancer Hospital Chinese Academy of Medical Sciences in Google Maps
Recruiting
One Study Center