Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer with Different HER2 Expression Patterns
NCT Number: NCT06551220
Acronym: HEROIC
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Metastatic Breast Cancer
Sponsor: Sun Yat-sen University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-10
Completion Date: 2024-09

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?

Primary Outcome Measures: 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 Outcome Measures: 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.
Other Outcome Measures: 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., 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.