Study on Neratinib and Capmatinib Combination for Metastatic and Inflammatory Breast Cancer with Abnormal HER-family and c-Met Pathway Activity

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05243641

Provider View

This clinical trial is testing a combination of two drugs, neratinib and capmatinib, to see if they can help control advanced breast cancer. The study also aims to find the highest safe dose of these drugs and evaluate their safety.

Patient Parameters

Program Overview

The purpose of this study is to determine if the combination of neratinib and capmatinib can effectively manage metastatic or locally advanced breast cancer. Researchers are also looking to find the highest dose of these drugs that patients can tolerate. Additionally, the study will assess the safety of this drug combination and the testing method used to measure cancer activity.

Description

This study is divided into two phases: Phase Ib and Phase II.

In Phase Ib, researchers will test different doses of neratinib and capmatinib to find the maximum dose that patients can safely tolerate. This phase uses a method called the Bayesian optimal interval (BOIN) design, which is similar to traditional methods but more flexible. Up to 18 patients will participate, with doses adjusted based on safety and side effects.

In Phase II, the study will focus on patients with previously treated HER2-negative metastatic breast cancer or metastatic inflammatory breast cancer. Participants will receive the combination of neratinib and capmatinib, with an additional drug for certain types of breast cancer. The goal is to see how well the treatment works, aiming for a 25% response rate. Up to 29 more patients will be enrolled, and an interim analysis will be conducted after 15 patients have been treated.

Eligibility Criteria

Exclusion Criteria

  • Recent cancer treatment within 2 weeks before starting the study, except for certain hormone therapies and palliative radiation for bone metastases.
  • Unstable or symptomatic brain metastases.
  • Unresolved side effects from previous cancer treatments, except for hair loss, skin changes, pain, or constipation.
  • Significant liver disease or recent severe flare-ups of existing conditions.
  • Known HIV infection with low CD4+ count or recent AIDS-related infections.
  • Active hepatitis B or C infections.
  • Severe infections or signs of infection shortly before starting the study.
  • Recent major surgery or need for major surgery during the study.
  • Lung diseases affecting daily activities or requiring treatment.
  • Heart conditions like long QT syndrome, recent heart attacks, or uncontrolled high blood pressure.
  • Inability to swallow or absorb study drugs due to digestive issues.
  • Use of certain medications that cannot be stopped before the study.
  • Pregnant or breastfeeding women.
  • Women who can become pregnant must use effective birth control during and after the study.
  • Men must use condoms during and after the study to prevent pregnancy and drug transfer.
  • Previous treatment with capmatinib, neratinib, or similar drugs for Phase II patients.

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