Trial of Trastuzumab Deruxtecan in Previously Treated HER2
ConditionBreast Cancer Metastatic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Men or women ≥18 years old.
Pathologically documented breast cancer that is unresectable or metastatic.
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 of American Pathologists (ASCO-CAP) guidelines.
Disqualifiers
History of myocardial infarction within 6 months before enrolment.
History of symptomatic congestive heart failure (New York Heart Association Class II to IV).
Corrected QT interval (QTc) Fridericia prolongation to >470 ms (females) or >450 ms (male) based on average of Screening 12 lead ECG.
Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
Trial design
Treatments tested in this trial
- Trastuzumab Deruxtecan
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
3Yale University06511, New HavenConnecticut, United States
Emory Winship Cancer Institute30322, AtlantaGeorgia, United States
University of Rochester Medical Center14642, RochesterNew York, United States
Sponsors and collaborators
Yale University
Lead sponsor
Daiichi Sankyo
Collaborator
AstraZeneca
Collaborator
Source ClinicalTrials.gov