Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer
Phase 2, Open Label Study of Patritumab Deruxtecan (U3-1402), an Anti-HER3-Antibody Drug Conjugate (ADC), in Patients With Advanced Breast Cancer, With Biomarker Analyses to Characterize Response to Therapy
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris + Daiichi Sankyo
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Evaluation of objective response rate (ORR) based on investigator assessment
Time frame: During treatment period, an average of 8 months
Secondary Endpoints
Evaluation of duration of response (DOR, investigator-assessed and as per retrospective central review)
Evaluation of progression free Survival (PFS), investigator-assessed and as per retrospective central review
Evaluation of clinical benefit ratio (CBR), investigator-assessed and as per retrospective central review
Eligibility Criteria
Inclusion Criteria: * Adults with histologically-confirmed HER2 negative, unresectable locally advanced or metastatic breast cancer that is hormone receptor positive (HR+) at the time of the first breast cancer diagnosis * Participants with a documented radiologic unresectable or metastatic progression * Participants may have received anthracyclines and taxanes as (neo) adjuvant treatment and must have received one line of chemotherapy for Advanced breast cancer (ABC), but not more than one line. Participants must have a clinically or radiologically documented evidence of tumor progression on or after cyclin dependent kinase 4/6 (CDK 4/ 6) inhibitor combined with endocrine therapy. Previous treatments with PI3K inhibitors, mTOR inhibitors, AKT-inhibitors and poly ADP ribose polymerase (PARP)-inhibitors are allowed * Participants must have a tumor site easily accessible to biopsy (with exception of bone metastasis) * Participants must have at least one radiologically measurable lesion …
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →