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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab Deruxtecan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab Deruxtecan | Drug | The patients received Trastuzumab Deruxtecan at a dose of 5.4 mg/kg every 3 weeks until disease progression or unacceptable adverse effects occurred. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoming Xie, MD, PhD | Contact | 86-020-87343806 | xiexm@sysucc.org.cn | |
| Yutian Zou, MD, PhD | Contact | 86-020-87343806 | zouyt@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoming Xie, MD, PhD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center | Recruiting | New Haven | Connecticut | 06510 | United States |
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Paraffin section
| From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months. |
| Disease control rate (DCR) | 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) | 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. |
| Dana-Farber Cancer Institute, Harvard Medical School | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| Fujian Cancer Hospital, Fujian Medical University | Recruiting | Fuzhou | Fujian | China |
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| The 10th Affiliated Hospital of Southern Medical University | Recruiting | Dongguan | Guangdong | China |
|
| The First People's Hospital of Foshan | Recruiting | Foshan | Guangdong | China |
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| The Sixth Affiliated Hospital, School of Medicine, South China University of Technology. | Recruiting | Foshan | Guangdong | China |
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| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| The Affiliated Panyu Central Hospital, Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 511400 | China |
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| Guangdong Provincial Hospital of Chinese Medicine | Recruiting | Guangzhou | Guangdong | China |
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| The Affiliated Cancer Hospital, Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
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| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
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| The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Recruiting | Guangzhou | Guangdong | China |
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| Cancer Hospital of Shantou University Medical College | Recruiting | Shantou | Guangdong | 515041 | China |
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| Yuebei People's Hospital of Shantou University | Recruiting | Shaoguan | Guangdong | China |
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| National Cancer Center Shenzhen Hospital | Recruiting | Shenzhen | Guangdong | China |
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| Shenzhen People's Hospital | Recruiting | Shenzhen | Guangdong | China |
|
| Zhongshan City People's Hospital | Recruiting | Zhongshan | Guangdong | China |
|
| The Fifth Affiliated Hospital of Sun Yat-sen University | Recruiting | Zhuhai | Guangdong | 519000 | China |
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| Changde Hospital, Xiangya School of Medicine, Central South University | Recruiting | Changde | Hunan | China |
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| Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University | Recruiting | Changsha | Hunan | 410013 | China |
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| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
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| The First Affiliated Hospital, Hengyang Medical School, University of South China | Recruiting | Hengyang | Hunan | China |
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| Affiliated Cancer Hospital of Inner Mongolia Medical University | Recruiting | Hohhot | Inner Mongolia | China |
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| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| Xinhua Hospital Afliated to Shanghai Jiaotong University | Recruiting | Shanghai | Shanghai Municipality | China |
|
| The Second Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
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