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NCT Number: NCT06551220

Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns

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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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Fujian Cancer Hospital, Fujian Medical University, Fuzhou, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoming Xie, MD, PhD

CONTACT

[email protected]

86-020-87343806

Yutian Zou, MD, PhD

CONTACT

[email protected]

86-020-87343806

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

HER2 Heterogeneity and Its Impact on Benefit From Trastuzumab Deruxtecan in Metastatic Breast Cancer

Acronym: HEROIC

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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