Efficacy and Safety of T-DXd in Patients With HER2-positive and HER2-low Metastatic Breast Cancer: a Real-world Study

NCT ID: NCT07108595

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-12-31

Brief Summary

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Evaluate the efficacy and safety of T-DXd in patients with HER2-positive and HER2-low metastatic breast cancer

Detailed Description

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The DESTINY-Breast trials established trastuzumab deruxtecan (T-DXd) as a treatment significantly improving outcomes in human epidermal growth factor receptor 2 (HER2)-positive and HER2-low metastatic breast cancer (MBC). However, real-world effectiveness is susceptible to confounding factors. This multicenter, real-world study aims to systematically evaluate the efficacy and safety of T-DXd in patients with HER2-positive and HER2-low MBC. Key clinicopathological parameters were to be integrated to develop an individualized prognostic prediction model, facilitating precision medicine implementation in clinical practice.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Observational Group

Patients receive T-DXd

T- Dxd

Intervention Type DRUG

T-DXd based therapy

Interventions

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T- Dxd

T-DXd based therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. female patients aged ≥18 years;
2. histologically confirmed HER2-positive (IHC 3+ or IHC 2+/FISH+) or HER2-low (IHC 1+ or IHC 2+/FISH-) disease;
3. radiologically confirmed recurrent or metastatic disease;
4. completion of ≥2 cycles of T-DXd therapy;
5. comprehensive medical documentation;
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤3;
7. measurable target lesions according to RECIST 1.1

Exclusion Criteria

1. history of interstitial lung disease
2. incomplete medical records
3. concurrent malignancies;
4. pregnancy or lactation
5. psychiatric disorders compromising treatment adherence
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jiangsu Provincial People's Hospital, Nanjing, JiangSu 210000

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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20250729TDXd

Identifier Type: -

Identifier Source: org_study_id

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