USOR 22333: Trial for 2L+ HER2+ MBC Ph2 Tucatinib combo w/ Doxil for HER2+ mBC (BRE 381)

Trial Protocol ID USOR 22333: Trial for 2L+ HER2+ MBC Ph2 Tucatinib combo w/ Doxil for HER2+ mBC (BRE 381)

Trial Description

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+ (IHC3+ or FISH+ by local testing) MBC
Prior tx with at least 1L anti-HER2 tx in metastatic setting or
relapsed w/in 6 mo of completion of adjuvant anti-HER2 tx
- 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