OncoMatch/Clinical Trials/NCT04965766
Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer
Is NCT04965766 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies U3-1402 for metastatic breast cancer.
Treatment: U3-1402 — This study aims to evaluate the efficacy and safety of U3-1402 in participants with advanced breast cancer (ABC). Participants have to be hormone-receptor positive (HR+) and have to be resistant to endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors. Participants may have received multiple lines of endocrine therapy with or without targeted therapies and must have received only one line of chemotherapy for ABC. Moreover, the immune effects, the predictors of resistance and response to treatment, the effect of the chemotherapy on deoxyribonucleic acid (DNA) replication will be assessed and will help identify the subgroups that will mostly benefit from the treatment. The pharmacokinetics of the product and the anti-drug antibody (ADA) will be also evaluated. A total of 99 participants are planned to be treated in the study. Participants will receive, every three weeks, a dose of U3-1402 equivalent to 5.6 mg/kg of body weight until progression or until unacceptable toxicity. Tumor evaluation will be performed every six weeks by the mean of a computed tomography for the thorax, abdomen and pelvis (TAP CT-scan) or a magnetic resonance imaging (MRI). Brain and/or bone CT scans will be also performed throughout the study for participants with brain and/or bone metastasis. A PET scan combined with contrast enhanced CT scan can replace all the above-mentioned imaging if performed at baseline considering that the same imaging technique should be used throughout the study. The safety of the product will be assessed at each cycle, through complete clinical exams, biological tests, electrocardiograms (ECGs), cardiac echographies (ECHOs) and through the collection of ongoing toxicities or adverse events.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) wild-type
HER2 negative
Required: ESR1 positive
hormone receptor positive (HR+)
Required: PR (PGR) positive
hormone receptor positive (HR+)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy — advanced/metastatic
must have received one line of chemotherapy for Advanced breast cancer (ABC), but not more than one line
Must have received: CDK4/6 inhibitor — combined with endocrine therapy
documented evidence of tumor progression on or after cyclin dependent kinase 4/6 (CDK 4/ 6) inhibitor combined with endocrine therapy
Cannot have received: anti-HER3 antibody
Prior treatment with an anti-HER3 antibody
Cannot have received: ADC containing an exatecan derivative that is a topoisomerase I inhibitor
ADC containing an exatecan derivative that is a topoisomerase I inhibitor
Lab requirements
Blood counts
adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to Cycle 1, Day 1
Kidney function
adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to Cycle 1, Day 1
Liver function
Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST/ALT <3 × ULN, which are not attributable to HBV or HCV infection
Cardiac function
Corrected QT interval higher than 470 ms for females and 450 ms for males according to Fridericia's formula (QTcF) and assessed based on triplicate ECGs, approximately 1 minute apart; Left ventricular ejection fraction (LVEF) less than 50% by either ECHO or cardiac MRI or multigated acquisition scan (MUGA); Resting systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg; Myocardial infarction within six months; Symptomatic congestive heart failure (NYHA Classes 2 to 4 within 28 days before treatment); Uncontrolled angina pectoris within six months; Cardiac arrhythmia requiring antiarrhythmic treatment
adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to Cycle 1, Day 1; cardiac criteria as listed in exclusion criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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