HKI-272 for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this research study is to determine how well neratinib works in treating breast cancer that has spread to the brain. Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2).In this research study, the investigators are looking to see how well neratinib works to decrease the size of or stabilize breast cancer that has spread to the brain. The investigators are also looking at how previous treatments have affected your thinking (or cognition) and how much neratinib reaches the central nervous system.
Will I have to stop taking my current medications?
The trial requires a 2-week period without chemotherapy, certain targeted therapies, or radiation before starting. Hormonal therapy must be stopped during the study, but bisphosphonates can continue if started before neratinib. Some epilepsy medications are not allowed.
How is the drug HKI-272 unique in treating breast cancer?
Who Is on the Research Team?
Rachel Freedman, M.D., M.P.H.
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults with invasive breast cancer that has spread to the brain (HER2-positive). Participants must have measurable brain lesions, not be on certain treatments like neratinib before, and can't be taking concurrent cancer therapies. Pregnant or breastfeeding individuals, those with specific medical conditions or allergies to similar drugs, and patients who cannot tolerate oral medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive neratinib daily, with additional treatments depending on cohort, for 4-week cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments including physical exams, imaging, and blood tests
Long-term follow-up
Participants' medical conditions are tracked for up to two years post-treatment via phone or mail
What Are the Treatments Tested in This Trial?
Interventions
- HKI-272
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Translational Breast Cancer Research Consortium
Collaborator
Puma Biotechnology, Inc.
Industry Sponsor