Alpelisib + Tucatinib for Breast Cancer
Trial Summary
What is the purpose of this trial?
This trial tests a combination of two drugs, tucatinib and alpelisib, in patients with a specific type of advanced breast cancer. These patients have a genetic mutation and a type of cancer that may not respond well to standard treatments. The drugs work by blocking signals that help cancer cells grow. Alpelisib is approved for treating certain types of advanced breast cancer.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot use certain medications that strongly affect liver enzymes (CYP3A4 and CYP2C8) within a specific time before starting the trial. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination Alpelisib and Tucatinib for breast cancer?
Alpelisib has shown effectiveness in treating certain types of breast cancer, particularly those with a specific genetic mutation (PIK3CA), when used with another drug called fulvestrant. Tucatinib has been effective in treating breast cancer that has spread to the brain. These findings suggest that the combination of Alpelisib and Tucatinib could be beneficial for breast cancer treatment.12345
What safety information is available for Alpelisib and Tucatinib in humans?
What makes the drug combination of Alpelisib and Tucatinib unique for breast cancer treatment?
Research Team
Elena Shagisultanova
Principal Investigator
University of Colorado, Denver
Eligibility Criteria
This trial is for adults with HER2-positive metastatic breast cancer that has a specific mutation (PIK3CA). Participants must understand the study and be willing to follow its procedures. They should have an ECOG performance status of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. People with severe medical conditions, recent anti-cancer therapy, pregnancy, certain drug hypersensitivities, or inability to swallow pills cannot join.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase Ib Treatment
Tolerability of tucatinib and alpelisib combination is confirmed and maximum tolerated dose determined. Therapy administered in 28-day cycles.
Phase II Treatment
Expansion of drug combination testing at maximum tolerated dose to determine progression-free survival rate.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Alpelisib (PI3K Inhibitor)
- Tucatinib (HER2 Inhibitor)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Criterium, Inc.
Lead Sponsor
Seagen Inc.
Industry Sponsor
Novartis
Industry Sponsor