Clinical Trial

Phase 2 Single Arm Trial with a Safety Lead-in of Tucatinib in Combination with Doxil for the Treatment of HER2+ Metastatic Breast Cancer (BRE 381)

MOA: Tucatinib is an oral tyrosine kinase inhibitor selective for HER2 Doxil is an anthracycline topoisomerase II inhibitor

Key Eligibility Criteria:

• Women, men with HER2+ metastatic breast cancer (IHC3+ or FISH+)
• Prior tx with at least 1L anti-HER2 therapy in metastatic setting or relapsed w/in 6 mo of completion of adjuvant anti-HER2 therapy
  • Prior tx with tucatinib in metastatic setting allowed
  • Prior tx with anthracycline (any setting) excluded
• Measurable disease per RECIST v1.1
• CNS Inclusion – patients must have one of the following:
  • No evidence of brain metastases
  • Untreated brain metastases not needing immediate local therapy. Lesions >2.0 cm require approval from Medical Monitor.
  • Previously treated brain metastases that are stable or have progressed but do not require immediate re-treatment
    • Time since WBRT ≥14 days prior to first dose of tx
    • Time since SRS ≥7 days prior to first dose of tx
    • Time since surgical resection ≥28 days