About this trial
This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2.
Eligibility criteria
Qualifiers
Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N5 based on the presence of an actionable mutation as defined in EAY191
Patients must have a HER2 amplified solid tumor except breast cancer.
If IHC is 0 or 1+, patient (pt) is NOT ELIGIBLE regardless of in situ hybridization (ISH)/FISH or next generation sequencing (NGS) status
If IHC is 3+, pt IS ELIGIBLE regardless of ISH/FISH or NGS status
Disqualifiers
None
Trial design
Treatments tested in this trial
- Biopsy Procedure
- Biospecimen Collection
- Computed Tomography
- Echocardiography Test
- Magnetic Resonance Imaging
- Multigated Acquisition Scan
- Neratinib Maleate
- Palbociclib
Treatment groups
Locations
188Sponsors and collaborators
National Cancer Institute (NCI)
Lead sponsor