Metastatic Breast CancerHEROICNCT06551220
Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns
An observational study of Metastatic Breast Cancer, run by Sun Yat-sen University at 26 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Trastuzumab Deruxtecan
- How many people
- 800 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 10 Oct 2022to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
26 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 2 countries
China24 sites, 24 recruiting
- Recruiting
Changde Hospital, Xiangya School of Medicine, Central South University
Changde, Hunan
Tao Wu, 86-0736-7788000, radiotherapy_wutao@qq.com
- Recruiting
Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, 410013
Quchang Ouyang, MD, 86-0731-89762160, oyqc1969@126.com
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Wenjun Yi, 0731-85295999, yiwenjun@csu.edu.cn
- Recruiting
The 10th Affiliated Hospital of Southern Medical University
Dongguan, Guangdong
Xiaoyu Chen, 86-0769-28637920, chenxy769@mail3.sysu.edu.cn
- Recruiting
The First People's Hospital of Foshan
Foshan, Guangdong
Lewei Zhu, 86-0757-83833633, zlwei@fsyyy.com
- Recruiting
The Sixth Affiliated Hospital, School of Medicine, South China University of Technology.
Foshan, Guangdong
Pangzhou Chen, 86-0757-89932927, lychenpz@scut.edu.cn
- Recruiting
Fujian Cancer Hospital, Fujian Medical University
Fuzhou, Fujian
Weiwei Huang, 86-591-62002050, haungstudenth@163.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Xiaoming Xie, MD, PhD, 86-020-87343806, xiexm@sysucc.org.cn
- Recruiting
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 511400
Songming Li, 86-020-34859190, 36602798@qq.com
- Recruiting
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong
Qianjun Chen, MD, 86-020-39318100, cqj55@163.com
- Recruiting
The Affiliated Cancer Hospital, Guangzhou Medical University
Guangzhou, Guangdong
Hongsheng Li, 86-020-66673666, lihongsheng@gzhmu.edu.cn
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Weige Tan, 86-020-83062114, tanweige@gzhmu.edu.cn
- Recruiting
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong
Mei Huang, 86-020-36591912, huangmeigztcm@163.com
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Yingkuan Shao, ykshao@zju.edu.cn
- Recruiting
The First Affiliated Hospital, Hengyang Medical School, University of South China
Hengyang, Hunan
Yuehua Li, 86-0734-8279467, liyuehua2020@stu.usc.edu.cn
- Recruiting
Affiliated Cancer Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
Xiu-Mei Wang, 86-0471-6575447, wangxiumei75@163.com
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Xiaoxiang Guan, MD, 86-025-83718142, xguan@njmu.edu.cn
- Recruiting
Xinhua Hospital Afliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality
Jianchun Gu, 021-26077653, gujianchun@126.com
- Recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
Haoming Wu, MD, 86-0754-88599616, ahand@126.com
- Recruiting
Yuebei People's Hospital of Shantou University
Shaoguan, Guangdong
Chuansheng Yang, 86-0751-691330, ychssmile@163.com
- Recruiting
National Cancer Center Shenzhen Hospital
Shenzhen, Guangdong
Caiwen Du, 86-0755-66618168, dusumc@aliyun.com
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong
Hong Hu, 86-0755-25533018, hu.hong@szhospital.com
- Recruiting
Zhongshan City People's Hospital
Zhongshan, Guangdong
Shien Cui, 86-0760-89880389, cuishiencse@163.com
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
Peijian Peng, MD, 86-756-2528015, pengpjian@163.com
United States2 sites, 2 recruiting
- Recruiting
Dana-Farber Cancer Institute, Harvard Medical School
Boston, Massachusetts, 02215
Paolo Tarantino, MD, PhD, Paolo_Tarantino@DFCI.HARVARD.EDU
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06510
Amin H. Nassar, MD, amin.nassar@yale.edu
About this study
Official title: 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?
- Conditions
- Metastatic Breast Cancer
- Being tested
- Trastuzumab Deruxtecan
- Keywords
- Breast Cancer, Trastuzumab Deruxtecan, HER2
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab DeruxtecanDrug
The patients received Trastuzumab Deruxtecan at a dose of 5.4 mg/kg every 3 weeks until disease progression or unacceptable adverse effects occurred.
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab Deruxtecan | Not described Receives: Drug: Trastuzumab Deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from T-DXd treatment initiation to disease progression or death from any cause.
Measured: 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 outcomes (1)
Overall survival (OS)
Overall survival (OS) is defined as the time from treatment initiation to death from any cause.
Measured: From date of T-DXd treatment initiation until the date of death from any cause, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start10 Oct 2022
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yutian Zou, Sun Yat-sen University
- Investigators
- Xiaoming Xie, MD, PhD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551220
- Sponsor's protocol ID
- SYSUCC-B2022-617-X01
- Acronym
- HEROIC
- Status last verified
- May 2026
- First submitted
- 9 Aug 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HER2 Heterogeneity and Its Impact on Benefit From Trastuzumab Deruxtecan in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06551220
- Acronym / sponsor ID
- HEROIC / SYSUCC-B2022-617-X01
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer, Trastuzumab Deruxtecan, HER2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab Deruxtecan | – | Drug: Trastuzumab Deruxtecan |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab DeruxtecanThe patients received Trastuzumab Deruxtecan at a dose of 5.4 mg/kg every 3 weeks until disease progression or unacceptable adverse effects occurred. | Drug | Trastuzumab Deruxtecan |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoming Xie, MD, PhD principal investigator
Sun Yat-Sen University Cancer Center
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Sun Yat-sen University at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoming Xie, MD, PhD (86-020-87343806, xiexm@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.