RecruitingMalignant Female Reproductive System NeoplasmMalignant Solid NeoplasmRecurrent Malignant Female Reproductive System Neoplasm

Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)

Eligible age

18+ yrs

Accepts

All genders

Locations

33 states

Healthy volunteers

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About this study

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.

Sponsor: National Cancer Institute (NCI)

You may qualify if…

✓ 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
✓ If IHC is 2+, ISH/FISH OR NGS must be positive for the patient to be ELIGIBLE. Otherwise, pt is NOT ELIGIBLE
✓ If IHC is unknown and…
✓ ISH/FISH is positive, independent of NGS results, the patient IS ELIGIBLE
✓ ISH/FISH is negative and NGS positive with ≥ 7 copies, the patient IS ELIGIBLE