Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil
- Registration Number
- NCT06231693
- Lead Sponsor
- AstraZeneca
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Trastuzumab-deruxtecan Trastuzumab deruxtecan -
- Primary Outcome Measures
Name Time Method Time to Next Treatment Through study completion, an average of 1 year
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Research Site
🇧🇷São Paulo, Brazil
Research Site🇧🇷São Paulo, Brazil