Tucatinib + T-DM1 for Breast Cancer
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does exclude those who have had certain treatments like tucatinib or similar drugs before. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination Tucatinib and T-DM1 for breast cancer?
Research shows that T-DM1, a combination of trastuzumab and a chemotherapy agent, is effective in treating HER2-positive breast cancer, especially in patients who have already tried other treatments. Tucatinib, when combined with T-DM1, is being developed as a new option for patients with advanced HER2-positive breast cancer, suggesting potential effectiveness.12345
Is the combination of Tucatinib and T-DM1 safe for treating breast cancer?
The combination of Tucatinib and T-DM1 has been studied for safety in patients with advanced HER2-positive breast cancer. Trastuzumab emtansine (T-DM1) has shown improved tolerability compared to some standard treatments, and Tucatinib is being developed as a targeted treatment. Overall, these treatments have been evaluated for safety in various studies, indicating they are generally safe for human use in the context of breast cancer.15678
What makes the drug Tucatinib + T-DM1 unique for breast cancer treatment?
Tucatinib + T-DM1 is unique because it combines an oral drug, Tucatinib, which specifically targets HER2 (a protein that promotes cancer cell growth), with T-DM1, an antibody-drug conjugate that delivers a chemotherapy agent directly to cancer cells. This combination offers a novel approach for patients with HER2-positive breast cancer who have already been treated with other therapies.127910
What is the purpose of this trial?
This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery.Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer.Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.
Research Team
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
This trial is for adults with advanced or metastatic HER2+ breast cancer that has worsened after previous treatment or if they couldn't tolerate the last therapy. They should be relatively healthy (ECOG score of 0 or 1) and may have brain metastases if stable, treated, or not requiring immediate intervention. People can't join if they've had certain recent anti-HER2 treatments, large untreated brain lesions, need high-dose steroids for brain symptoms, have leptomeningeal disease, or uncontrolled seizures.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tucatinib or placebo in combination with T-DM1 in 21-day cycles
Progression Assessment
Participants are assessed for disease progression every 6 weeks for the first 24 weeks, and every 9 weeks thereafter
Follow-up
Participants are monitored for overall survival and progression-free survival after treatment
Treatment Details
Interventions
- Placebo
- T-DM1
- Tucatinib
T-DM1 is already approved in European Union, United States, Canada, Japan, China for the following indications:
- Breast cancer
- HER2-positive breast cancer
- HER2-positive breast cancer
- HER2-positive breast cancer
- HER2-positive breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seagen Inc.
Lead 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
Seagen, a wholly owned subsidiary of Pfizer
Lead Sponsor