Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer

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 w

Trial Details

NCT ID
NCT04965766
Phase
PHASE2
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • U3-1402
Locations (sample)
  • Dijon, France|47.31344,5.01391
  • Limoges, France|45.83362,1.24759
  • Lyon, France|45.74906,4.84789
  • Marseille, France|43.29695,5.38107
  • Montpellier, France|43.61093,3.87635

Key Eligibility Criteria

  • Adults with histologically-confirmed HER2 negative, unresectable locally advanced or metastatic breast cancer that is hormone receptor positive (HR…
  • 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 …
  • Participants must have a tumor site easily accessible to biopsy (with exception of bone metastasis)

For full eligibility, visit ClinicalTrials.gov.

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