Triple Drug Combo for Advanced Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to evaluate the safety and efficacy of the three-drug combination of tucatinib, trastuzumab, and eribulin in patients with de novo and recurrent unresectable metastatic HER-2/neu positive breast cancer as assessed by ORR, PFS and OS after prior treatment with a taxane, trastuzumab, and T-DM1.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently on warfarin or other coumarin derivatives, or if you have used strong CYP3A4 or CYP2C8 inhibitors or inducers recently. It's best to discuss your specific medications with the trial team.
Is the triple drug combo for advanced breast cancer safe?
The combination of eribulin and trastuzumab has been shown to be generally safe and well-tolerated in patients with advanced HER2-positive breast cancer. Common side effects include neutropenia (low white blood cell count), which is manageable, and no severe heart issues were observed. However, regular monitoring of heart function is recommended.12345
What makes the triple drug combo of Eribulin, Trastuzumab, and Tucatinib unique for advanced breast cancer?
What data supports the effectiveness of the triple drug combo for advanced breast cancer?
The combination of HER2-targeted drugs like trastuzumab (Herceptin) and tucatinib (Tukysa) has shown to significantly improve outcomes for patients with HER2-positive advanced breast cancer. Additionally, eribulin has been proven to extend overall survival in patients with advanced breast cancer who have undergone multiple prior treatments.1112131415
Who Is on the Research Team?
Hank Kaplan, MD
Principal Investigator
henry.kaplan@swedish.org
Are You a Good Fit for This Trial?
This trial is for adults with HER2+ breast cancer that's advanced and can't be surgically removed. Participants must have had prior treatments including trastuzumab and a taxane, but not necessarily tucatinib. They should be in relatively good health otherwise, able to follow the study plan, and women of childbearing age must test negative for pregnancy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tucatinib, trastuzumab, and eribulin in 21-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Eribulin
- Trastuzumab
- Tucatinib
Eribulin is already approved in European Union, United States, Japan, Canada for the following indications:
- Locally advanced or metastatic breast cancer
- Metastatic breast cancer
- Liposarcoma
- Breast cancer
- Soft tissue sarcoma
- Metastatic breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Criterium, Inc.
Lead Sponsor