Testing Neratinib Alone or with Palbociclib for HER2+ Solid Tumors

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06126276

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This study is exploring whether neratinib alone or combined with palbociclib is more effective in treating HER2 positive solid tumors. These drugs may help slow or stop cancer growth by targeting specific proteins.

Patient Parameters

Program Overview

This phase II study is testing two treatments for patients with HER2 positive solid tumors. It compares the effects of neratinib alone to a combination of neratinib and palbociclib. Both drugs are kinase inhibitors, which means they block certain proteins that help cancer cells grow. By doing this, they may slow down or stop the spread of cancer cells. The study aims to see if using both drugs together can shrink or stabilize tumors that have high levels of a protein called HER2.

Description

The main goal of this study is to see how well the combination of neratinib and palbociclib works compared to neratinib alone in patients with HER2 positive gynecologic cancers and other solid tumors. Researchers will look at how long patients live without their cancer getting worse.

Other goals include:

  • Checking how many patients' tumors shrink or stay the same for at least 16 weeks.
  • Looking at overall survival rates.
  • Observing side effects, especially severe ones.
  • Collecting tissue samples to study genetic changes in the tumors.

The study will also explore if certain genetic markers in the blood or tumor tissue can predict how well patients respond to treatment.

Participants will be randomly assigned to one of two groups:

  • Group 1: Patients take neratinib daily. If their cancer progresses, they may switch to the second group.
  • Group 2: Patients take neratinib daily and palbociclib for 21 days in each cycle.

Both groups will have regular heart scans, imaging tests, and blood samples taken. Some may also have tumor biopsies. After treatment, patients will be monitored every three months for two years.

Eligibility Criteria

Inclusion Criteria

  • Must be part of the EAY191 study and assigned to this trial based on specific genetic changes.
  • Have a HER2 positive solid tumor (not breast cancer) with at least 7 copies of HER2.
  • Cancer must be recurring or persistent.
  • No known loss of the RB1 gene.
  • Must agree to a tumor biopsy or have recent tissue samples available.
  • Must have measurable disease with at least one tumor that can be measured.
  • Treated brain metastases are allowed if stable for 3 months without steroids.
  • No leptomeningeal disease.
  • Can have had up to 5 previous treatments.
  • Previous treatment with trastuzumab or pertuzumab is allowed.
  • No previous treatment with CDK4/6 inhibitors.
  • No cancer treatment within 3 weeks before joining the study.
  • Must be 18 or older.
  • Must have a performance status of 2 or less.
  • Not pregnant or nursing.
  • Meet specific blood count and organ function criteria.
  • No active infections needing IV antibiotics.
  • No serious digestive issues or lung disease causing breathing problems.
  • No allergies to the study drugs.

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