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 groupSponsors and collaborators
Source ClinicalTrials.gov