Efficacy and Safety of T-DXd in Patients With HER2-positive and HER2-low Metastatic Breast Cancer: a Real-world Study
- Conditions
- Breast Cancer
- Interventions
- Drug: T- Dxd
- Registration Number
- NCT07108595
- Brief Summary
Evaluate the efficacy and safety of T-DXd in patients with HER2-positive and HER2-low metastatic breast cancer
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 142
- 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
- history of interstitial lung disease
- incomplete medical records
- concurrent malignancies;
- pregnancy or lactation
- psychiatric disorders compromising treatment adherence
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational Group T- Dxd Patients receive T-DXd
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) 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 Outcome Measures
Name Time Method The Number of Participants Who Experienced Adverse Events (AE) 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).
Trial Locations
- Locations (1)
Jiangsu Provincial People's Hospital, Nanjing, JiangSu 210000
🇨🇳Nanjing, Jiangsu, China
Jiangsu Provincial People's Hospital, Nanjing, JiangSu 210000🇨🇳Nanjing, Jiangsu, China