Title: A phase II study of the safety, tolerability and antitumor activity of tucatinib in combination with eribulin and trastuzumab in patients with pretreated unresectable locally advanced or metastatic HER2+ breast cancer
Contact: Michele La Badie from Criterium, Inc.
Description: Researchers are conducting a phase 2 trial to test the combination of tucatinib, trastuzumab, and eribulin in patients with previously treated, unresectable, locally advanced or metastatic HER2-positive breast cancer.
Patients will receive trastuzumab intravenously once during each 21-day cycle at a loading dose of 8 mg/kg. However, if patients had received trastuzumab within the 4 weeks prior, the initial dose of trastuzumab will be delivered at 6 mg/kg. In some cases, trastuzumab may be administered weekly to compensate for changes in treatment schedule.
Patients will receive oral tucatinib at 300 mg twice daily during each cycle. Eribulin will be administered intravenously over 2-5 minutes at a dose of 1.4mg/m2 on days 1 and 8 of each cycle.
The primary outcomes are related to safety and tolerability. Secondary outcomes are related to efficacy.
To be eligible for this study, patients must be 18 years of age or older and have HER2-positive breast cancer. They must have progression of unresectable, locally advanced or metastatic breast cancer after their last systemic therapy or be intolerant of their last systemic therapy.
They must also have received previous treatment with trastuzumab and a taxane in the metastatic setting, have disease recurrence within 6 months of receiving a taxane in the adjuvant or neoadjuvant setting, or have a contraindication for their use. Prior treatment with tucatinib and trastuzumab deruxtecan, capecitabine, or T-DM1 is allowed. For a complete list of eligibility criteria, please see the reference.
This study is sponsored by Criterium, Inc.
ClinicalTrials.gov. A phase II study of the safety, tolerability and antitumor activity of tucatinib in combination with eribulin and trastuzumab in patients with pretreated unresectable locally advanced or metastatic HER2+ breast cancer. NCT05458674. Accessed February 21, 2023.