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

The First Affiliated Hospital with Nanjing Medical University142 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

142

Conditions

Breast Cancer

Interventions

T- DxdDRUG

T-DXd based therapy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Jiangsu Provincial People's Hospital, Nanjing, JiangSu 210000

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

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.

Time frame: 2 years

Secondary Outcomes

The Number of Participants Who Experienced Adverse Events (AE)

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).

Time frame: 2 years

Data from ClinicalTrials.gov

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