At a glance
ClinicalIndex Comparison Record- ✓Prior enrollment on EAY191 with treatment assignment to ComboMATCH EAY191-N5 based on actionable mutation
- ✓HER2 amplified solid tumor except breast cancer with specific IHC/ISH/FISH/NGS criteria
- ✓Recurrent or persistent disease
- ✓No RB1 loss or deletion including copy number loss or deleterious mutation
- ✕RB1 loss or deletion including copy number loss or deleterious mutation
- ✕Leptomeningeal disease
- ✕Prior therapy with HER2 targeting tyrosine kinase inhibitors such as neratinib or tucatinib
- ✕Prior therapy with CDK4/6 inhibition
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Trial of Neratinib, A Pan-ERBB Inhibitor, Alone or in Combination With Palbociclib, a CDK4/6 Inhibitor, in Patients With HER2+ Gynecologic Cancers and Other Solid Tumors: A ComboMATCH Treatment Trial
In Brief
A Phase 2 clinical trial evaluating Biopsy Procedure, Biospecimen Collection, and 6 other interventions for Malignant Female Reproductive System Neoplasm and 3 related conditions. Currently recruiting, targeting 70 participants across 188 sites in 2 countries.
Signals
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may crossover to Arm II. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.
Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 and palbociclib PO QD on days 1-21 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.
Interventions
Undergo tumor biopsy
Undergo collection of blood samples
Undergo CT scan
Undergo ECHO
Undergo MRI
Undergo MUGA
Given PO
Given PO