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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Trastuzumab Deruxtecan
DrugParticipants 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Trastuzumab DeruxtecanExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate
The confirmed Objective Response Rate to Trastuzumab Deruxtecan by RECIST (Response Evaluation Criteria In Solid Tumors) defined as the cumulative rate of complete response (CR) rate and partial response (PR) rates, evaluated according to mRECIST v1.1
Time frame
After cycle 3, approximately 63 daysSecondary outcomes
1
Objective Response Rate (ORR) Comparison by HER2 Status
To assess and compare the Objective Response Rates (ORRs) between two subgroups of patients defined by their HER2 status. Patients will be classified into two subgroups: HER2 detectable and HER2 non-detectable. The ORR will be measured based on the proportion of patients in each subgroup who achieve a predefined response (complete response or partial response) to the treatment regimen, according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
Time frame
through study completion, an average of 1 year2
Correlation between HER2 protein expression
To explore and evaluate the association between HER2 protein expression value measured by the HS-HER2 assay in the CLIA lab setting with objeective response and clinical benefit from T-DXd.
Time frame
Last follow up visit (40 days [+7] from last dose)3
Progression Free Survival (PFS)
Progression Free Survival based on investigator assessment, in all subjects
Time frame
From the date of enrolment to the earliest date of the first objective documentation of radiographic disease progression according to mRECIST version 1.1 or death due to any cause. up to 3 years4
Overall Survival (OS)
Overall Survival in all subjects
Time frame
(every 3 months +/-14 days) for up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Daiichi Sankyo
Collaborator
AstraZeneca
Collaborator
Breast Cancer Research Foundation
Collaborator
Source ClinicalTrials.gov