Breast Cancer, Metastatic Cancer
Conditions
Keywords
Trastuzumab deruxtecan, Sacituzumab govitecan, Efficacy, Safety, Brain metastasis, ILD
Brief summary
The study aims to evaluate real-world efficacy and toxicity data of treatment with Trastuzumab deruxtecan (T-DXd), a HER2-targeting ADC and sacituzumab govitecan (SG), a TROP-2-targeting ADC in pretreated patients with advanced breast cancer.
Detailed description
Antibody-drug conjugates (ADCs) have significantly changed the therapeutic landscape of advanced breast cancer. Trastuzumab deruxtecan (T-DXd), a HER2-targeting ADC and sacituzumab govitecan (SG), a TROP-2-targeting ADC, recently demonstrated superior efficacy over standard of care treatments depending on breast cancer subtype. The study aims to evaluate real-world efficacy and toxicity data of treatment with T-DXd and SG in pretreated patients with advanced breast cancer. This study includes a retrospective/prospective multicenter review of medical records of patients with advanced breast cancer who received treatment with T-DXd and SG at Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG).
Interventions
Patients with advanced breast cancer treated with ADCs
Sponsors
Hellenic Cooperative Oncology Group
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed metastatic/recurrent breast cancer * 18 years of age * Triple-negative (TNBC), HER2-positive and/or hormone receptor positive advanced breast cancer * Treatment with an ADC at any of line of treatment * Treatment with at least one cycle of T-DXd and/or SG
Exclusion criteria
* NA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint was toxicity rate of each drug | From the initiation of ADC to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, throughout study completion, up to 24 months | Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS) | From the date of disease progression to the date of death from any cause or last contact, throughout study completion,up to 24 months |
Countries
Greece
Outcome results
None listed