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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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