Tucatinib for Metastatic Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how well tucatinib works for people with HER2+ cancers that have spread to the brain. The study aims to understand how the body absorbs and processes tucatinib and explores why some cancer cells resist treatment over time. It involves different groups: those new to tucatinib, those already using it, and those with other types of HER2+ cancers like lung or colon cancer. Suitable candidates for this trial have HER2+ breast, lung, esophagogastric, or colorectal cancer that has spread to the brain and are planning brain surgery. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use certain drugs that affect liver enzymes (CYP2C8 or CYP3A4) close to starting the trial. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that tucatinib is likely to be safe for humans?
Research shows that tucatinib is generally well-tolerated in patients with HER2-positive cancers. In earlier studies, about 26% of patients experienced serious side effects, including diarrhea (4%), vomiting (2.5%), and nausea (2%). Some patients also reported abdominal pain.
Serious risks, such as sudden death and severe infections (sepsis), were rare, occurring in about 2% of patients. Tucatinib is often combined with trastuzumab, which can help slow cancer growth and may extend patients' lives.
Overall, tucatinib has been approved for treating other HER2-positive cancers, supporting its safety. However, individual reactions can vary. Discuss potential risks and benefits with a healthcare professional.12345Why do researchers think this study treatment might be promising?
Tucatinib is unique because it specifically targets the HER2 protein, a common culprit in aggressive breast cancers, including those that have spread to the brain. Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, tucatinib's precision minimizes damage to healthy cells, potentially reducing side effects. Researchers are excited about its ability to penetrate the blood-brain barrier, offering hope for patients with brain metastases, a challenging area for treatment. This targeted approach could lead to more effective control of the disease with fewer side effects compared to existing treatments.
What evidence suggests that tucatinib could be an effective treatment for metastatic breast cancer?
Research has shown that tucatinib effectively treats HER2-positive metastatic breast cancer, even when it spreads to the brain. In this trial, participants will divide into different cohorts to receive tucatinib. One cohort will include patients with documented radiological and/or clinical CNS progression who have not previously received tucatinib. Another cohort will consist of patients already on tucatinib. Real-world evidence also indicates that tucatinib works well for patients who have tried other treatments. When combined with drugs like trastuzumab and capecitabine, tucatinib showed better results than some other drug combinations. Overall, tucatinib offers hope for those with HER2-positive cancers resistant to other treatments.46789
Who Is on the Research Team?
Andrew Seidman, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
Adults with HER2+ cancers that have spread to the brain, able to swallow pills, and expected to live more than 12 weeks. They should not have decision-making impairments or significant other illnesses as judged by a doctor. Women must test negative for pregnancy and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Treatment
Participants receive tucatinib at a standard dose of 300 mg orally twice daily for 4 days prior to surgery
Surgery
Participants undergo clinically indicated brain surgery to resect HER2+ brain metastases
Follow-up
Participants are monitored for safety and effectiveness after surgery and treatment
Post-operative Monitoring
Participants may continue tucatinib post-operatively at the discretion of the treating oncologist with monitoring as per clinical routine
What Are the Treatments Tested in This Trial?
Interventions
- Tucatinib
Tucatinib is already approved in United States, European Union, Switzerland for the following indications:
- Metastatic HER2-positive breast cancer
- RAS wild-type HER2-positive colorectal cancer
- HER2-positive locally advanced or metastatic breast cancer
- Metastatic HER2-positive breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Seagen Inc.
Industry Sponsor
Dr. Roger Dansey
Seagen Inc.
Chief Medical Officer since 2018
MD from University of Witwatersrand
David R. Epstein
Seagen Inc.
Chief Executive Officer since 2022
BSc in Pharmacy from Rutgers University, MBA from Columbia University