Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns
HEROIC
HER2 Heterogeneity and Its Impact on Benefit From Trastuzumab Deruxtecan in Metastatic Breast Cancer
1 other identifier
observational
800
2 countries
26
Brief 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 of trastuzumab deruxtecan in metastatic breast cancer?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2022
CompletedFirst Submitted
Initial submission to the registry
August 9, 2024
CompletedFirst Posted
Study publicly available on registry
August 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
CompletedMay 22, 2026
May 1, 2026
3.7 years
August 9, 2024
May 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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)
From date of T-DXd treatment initiation until the date of death from any cause, assessed up to 60 months.
Other Outcomes (3)
Objective response rate (ORR)
From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months.
Disease control rate (DCR)
From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months.
Clinical benefit rate (CBR)
From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months.
Study Arms (1)
Trastuzumab Deruxtecan
Interventions
The patients received Trastuzumab Deruxtecan at a dose of 5.4 mg/kg every 3 weeks until disease progression or unacceptable adverse effects occurred.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Yale Cancer Center
New Haven, Connecticut, 06510, United States
Dana-Farber Cancer Institute, Harvard Medical School
Boston, Massachusetts, 02215, United States
Fujian Cancer Hospital, Fujian Medical University
Fuzhou, Fujian, China
The 10th Affiliated Hospital of Southern Medical University
Dongguan, Guangdong, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
The Sixth Affiliated Hospital, School of Medicine, South China University of Technology.
Foshan, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 511400, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
The Affiliated Cancer Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
Yuebei People's Hospital of Shantou University
Shaoguan, Guangdong, China
National Cancer Center Shenzhen Hospital
Shenzhen, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000, China
Changde Hospital, Xiangya School of Medicine, Central South University
Changde, Hunan, China
Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, 410013, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital, Hengyang Medical School, University of South China
Hengyang, Hunan, China
Affiliated Cancer Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Xinhua Hospital Afliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Biospecimen
Paraffin section
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoming Xie, MD, PhD
Sun Yat-Sen University Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 9, 2024
First Posted
August 13, 2024
Study Start
October 10, 2022
Primary Completion
July 1, 2026
Study Completion
July 1, 2026
Last Updated
May 22, 2026
Record last verified: 2026-05