Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns (HEROIC)

May 21, 2026 updated by: Yutian Zou, Sun Yat-sen University

HER2 Heterogeneity and Its Impact on Benefit From Trastuzumab Deruxtecan in Metastatic Breast Cancer

The purpose of this observational study is to learn about the HER2 heterogeneity and its impact on benefit from trastuzumab deruxtecan in metastatic breast cancer. The main question it aims to answer is:

- Does the heterogeneity of HER2 expression level and spatial distribution in different tissues affect the efficacy of trastuzumab deruxtecan in metastatic breast cancer?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Cancer Hospital, Fujian Medical University
        • Contact:
    • Guangdong
      • Dongguan, Guangdong, China
        • Recruiting
        • The 10th Affiliated Hospital of Southern Medical University
        • Contact:
      • Foshan, Guangdong, China
        • Recruiting
        • The First People's Hospital of Foshan
        • Contact:
      • Foshan, Guangdong, China
        • Recruiting
        • The Sixth Affiliated Hospital, School of Medicine, South China University of Technology.
        • Contact:
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial Hospital of Chinese Medicine
        • Contact:
          • Qianjun Chen, MD
          • Phone Number: 86-020-39318100
          • Email: cqj55@163.com
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • The Affiliated Cancer Hospital, Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 511400
        • Recruiting
        • The Affiliated Panyu Central Hospital, Guangzhou Medical University
        • Contact:
      • Shantou, Guangdong, China, 515041
        • Recruiting
        • Cancer Hospital of Shantou University Medical College
        • Contact:
          • Haoming Wu, MD
          • Phone Number: 86-0754-88599616
          • Email: ahand@126.com
      • Shaoguan, Guangdong, China
        • Recruiting
        • Yuebei People's Hospital of Shantou University
        • Contact:
      • Shenzhen, Guangdong, China
        • Recruiting
        • ShenZhen People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China
        • Recruiting
        • National Cancer Center Shenzhen Hospital
        • Contact:
      • Zhongshan, Guangdong, China
        • Recruiting
        • Zhongshan City People's Hospital
        • Contact:
      • Zhuhai, Guangdong, China, 519000
        • Recruiting
        • The Fifth Affiliated Hospital of Sun Yat-sen University
        • Contact:
    • Hunan
      • Changde, Hunan, China
        • Recruiting
        • Changde Hospital, Xiangya School of Medicine, Central South University
        • Contact:
      • Changsha, Hunan, China
        • Recruiting
        • The second Xiangya hospital of central south university
        • Contact:
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
        • Contact:
      • Hengyang, Hunan, China
        • Recruiting
        • The First Affiliated Hospital, Hengyang Medical School, University of South China
        • Contact:
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China
        • Recruiting
        • Affiliated Cancer Hospital of Inner Mongolia Medical University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Xinhua Hospital Afliated to Shanghai Jiaotong University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
    • Massachusetts
      • Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study is a multicenter, retrospective study led by the Sun Yat-sen University Cancer Center. A total of 16 centers are planned to participate in the study, and it aims to include patients with advanced or locally unresectable breast cancer who have received treatment with T-DXd.

Description

Inclusion Criteria:

  • Patients with advanced or locally unresectable breast cancer;
  • Treated with T-DXd (DS-8201, trastuzumab deruxtecan) regardless of line of therapy, HR, and HER2 expression level;
  • HER2 immunohistochemistry staining information of the primary lesion or metastatic/recurrent lesion;
  • Measurable lesions with treatment response results that can be evaluated through imaging examinations;
  • Able to follow up with the latest progression-free survival or overall survival.

Exclusion Criteria:

  • Patients with missing basic clinical information or HER2 immunohistochemistry staining information;
  • Patients with missing pathological results for both primary and metastatic/recurrent lesions;
  • Patients with no measurable lesions and unable to evaluate T-DXd treatment response;
  • Discontinue T-DXd therapy for unacceptable adverse events or other reasons;
  • Patients lost to follow-up after T-DXd treatment.

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trastuzumab Deruxtecan
Drug: Trastuzumab Deruxtecan
The patients received Trastuzumab Deruxtecan at a dose of 5.4 mg/kg every 3 weeks until disease progression or unacceptable adverse effects occurred.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: From date of T-DXd treatment initiation until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 60 months.
Progression-free survival (PFS) is defined as the time from T-DXd treatment initiation to disease progression or death from any cause.
From date of T-DXd treatment initiation until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 60 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From date of T-DXd treatment initiation until the date of death from any cause, assessed up to 60 months.
Overall survival (OS) is defined as the time from treatment initiation to death from any cause.
From date of T-DXd treatment initiation until the date of death from any cause, assessed up to 60 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months.
The Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was used as the standard for evaluating treatment response to T-DXd. The response was evaluated based on the change in the tumor relative to baseline and was categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). Objective response rate (ORR) is defined as the proportion of patients who achieved CR or PR.
From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months.
Disease control rate (DCR)
Time Frame: From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months.
The Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was used as the standard for evaluating treatment response to T-DXd. The response was evaluated based on the change in the tumor relative to baseline and was categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). Disease control rate (DCR) was defined as the proportion of patients who achieved CR, PR, or SD.
From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months.
Clinical benefit rate (CBR)
Time Frame: From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months.
The Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was used as the standard for evaluating treatment response to T-DXd. The response was evaluated based on the change in the tumor relative to baseline and was categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The clinical benefit rate (CBR) was defined as the proportion of patients who achieved CR, PR, or SD for at least 24 weeks.
From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Xiaoming Xie, MD, PhD, Sun Yat-sen University Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUCC-B2022-617-X01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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