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

ConditionsMalignant Female Reproductive System Neoplasm Malignant Solid Neoplasm Recurrent Malignant Female Reproductive System Neoplasm Recurrent Malignant Solid Neoplasm

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorNational Cancer Institute (NCI)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Biopsy Procedure
Procedure/Surgery
Undergo tumor biopsy
Biospecimen Collection
Procedure/Surgery
Undergo collection of blood samples
Computed Tomography
Procedure/Surgery
Undergo CT scan
Echocardiography Test
Procedure/Surgery
Undergo ECHO
Magnetic Resonance Imaging
Procedure/Surgery
Undergo MRI
Multigated Acquisition Scan
Procedure/Surgery
Undergo MUGA
Neratinib Maleate
Drug
Given PO
Palbociclib
Drug
Given PO

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Arm I (neratinib maleate)Active comparator 7 interventions

Group B: Arm II (neratinib maleate, palbociclib)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

Progression free survival

The stratified log-rank statistic will be used to draw inferences about the relative activity of the two regimens. Characterized by medians and Kaplan-Meier (KM) curves.

Time frame

From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 2 years

Secondary outcomes

Overall survival

The impact of treatment on the hazard of death can be investigated with time dependent covariates.

Time frame

Up to 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov

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