Search / Trial NCT06231693

Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil

Launched by ASTRAZENECA · Jan 26, 2024

Trial Information

Current as of October 08, 2024

Terminated

Keywords

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.

Gender

ALL

Eligibility criteria

  • 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.

About Astrazeneca

AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.

Locations

Porto Alegre, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0