Open-label Single-arm Phase 2 Trial of Trastuzumab Deruxtecan in Previously Treated HER2-Immunohistochemistry (IHC) 0 Advanced Breast Cancer
Yale University
Summary
The purpose of this study is to test the good and bad effects of a drug called trastuzumab deruxtecan (T-DXd) in adult patients with metastatic HER2-negative breast cancer and which patients might benefit the most from T-DXd.
Description
HER2 (human epidermal growth factor receptor 2) is a gene that can play a role in the development of breast cancer. Genes like HER2 and the proteins they make influence how a breast cancer behaves and how it might respond to a specific treatment. A score of 0 on the HER2 immunohistochemistry (IHC) test indicates that breast tissue is HER2-negative. Drugs that fight cancer by targeting the growth of HER2 genes, such as the monoclonal antibody trastuzumab, have not traditionally been used in patients with HER2-negative tumors because trastuzumab works by attaching to HER2 and stopping cancer ce…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Must be competent and able to comprehend, sign, and date an Institutional Review Board (IRB) approved ICF before performance of any study-specific procedures or tests. 2. Men or women ≥18 years old. 3. Pathologically documented breast cancer that is unresectable or metastatic. 4. 4.Tumor biopsies have always shown HER2-IHC 0 (\<10% membrane staining, including 0 null and 0 ultralow) in all prior biopsies and never previously HER2-positive (IHC 3+ or ISH+) or HER2-low (1+, or 2+ ISH-) on prior pathology testing according to American Society of Clinical Oncology College o…
Interventions
- DrugTrastuzumab Deruxtecan
Participants will receive the study drug trastuzumab deruxtecan (T-DXd) by IV infusion every 21 days. The number of treatment cycles will depend on how participants respond to treatment.
Locations (2)
- Yale UniversityNew Haven, Connecticut
- University of Rochester Medical CenterRochester, New York