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

Recruiting

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Trastuzumab Deruxtecan

• Registration Number: NCT06551220
• Lead Sponsor: Sun Yat-sen University

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-10
• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-08-12
• Study First Posted: 2024-08-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 800

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trastuzumab Deruxtecan	Trastuzumab Deruxtecan	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	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 Outcome Measures

Name	Time	Method
Overall survival (OS)	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.

Trial Locations

Locations (23)

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, 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

Yuebei People's Hospital of Shantou University; 🇨🇳 Shaoguan, Guangdong, China

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