Breast Cancer
Conditions
Brief summary
A national, multicenter, retrospective, observational study (Real-World Evidence-RWE) aimed to assess the efficacy of Trastuzumab-deruxtecan (T-DXd) in patients with triple-negative (RE\<10%) metastatic HER2-Low breast cancer.
Detailed description
Data from study DESTINY-04 have established T-DXd as the standard second-line treatment for HER2-Low breast tumors. In that study, about 90% of the population had estrogen-positive receptor (ER+) tumors, under-representing negative ER population. The investigators propose to assess T-DXd efficacy in HER2-Low/ER ≤10% patients in Brazilian population by means of a RWE analysis. Endpoints will be assessment of time to the next treatment, objective response rate, and real-world progression-free survival and real-world overall survival.
Interventions
DRUGTrastuzumab deruxtecan
Patients with RE\<10% and HER2-Low breast cancer that have received Trastuzumab-deruxtecan in the metastatic setting
Sponsors
Hospital Israelita Albert Einstein
AstraZeneca
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged above 18 years old; * Have advanced, hormone receptor negative (ER ≤10%), HER2-Low (1+ or 2+/FISH negative) breast cancer; * Have been treated with at least one trastuzumab-deruxtecan dose for advanced disease (incurable) as a second or later line; * Do not have active CNS metastatic lesions, characterized as stable, asymptomatic lesions and with no targeted treatment for at least 6 months.
Exclusion criteria
* Have been previously treated with trastuzumab-deruxtecan (neoadjuvant, adjuvant, other neoplasms); * Have other active neoplasms (except from non-melanoma skin tumors); * Have serious or active non-oncology lung diseases; * Have other primary and concurrent breast tumor with differing receptor profiles.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Next Treatment | Through study completion, an average of 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | Through study completion, an average of 18 months | — |
| Real World Progression Free Survival | Through study completion, an average of 18 months | — |
| Real World Overall Survival | Through study completion, an average of 18 months | — |
| Epidemiological Features | Through study completion, an average of 18 months | Age, comorbidities, somatic mutations, pattern of HER2 testing. |
Countries
Brazil
Outcome results
None listed