Breast Cancer
Conditions
Keywords
HER2-positive, HER2-low, T-DXd, Real-world study
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.
Interventions
DRUGT- Dxd
T-DXd based therapy
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Outcome results
None listed