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

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

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

Jiangsu Provincial People's Hospital, Nanjing, JiangSu 210000

Nanjing, Jiangsu, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

history of interstitial lung disease
incomplete medical records
concurrent malignancies;
pregnancy or lactation
psychiatric disorders compromising treatment adherence

Treatment and study plan

T- Dxd

Drug

T-DXd based therapy

Primary outcomes

Progression Free Survival (PFS)

Time frame: 2 years

Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.

Secondary outcomes

The Number of Participants Who Experienced Adverse Events (AE)

Time frame: 2 years

Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Aug 7, 2025
Registry last updated: Aug 7, 2025

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.

Published trials that share one or more normalized conditions with this study.

Completed