Testing Fulvestrant and Binimetinib for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05554354

Provider View

This study is exploring whether adding binimetinib to the usual treatment with fulvestrant can better control breast cancer that has spread and has an NF1 genetic change. The trial aims to see if this combination can shrink tumors and keep them stable longer than fulvestrant alone.

Patient Parameters

Program Overview

This clinical trial is testing a new treatment approach for patients with hormone receptor-positive breast cancer that has spread to other parts of the body and has an NF1 genetic mutation. The study compares the usual treatment, fulvestrant, with a combination of fulvestrant and a new drug, binimetinib. Fulvestrant works by blocking estrogen receptors on cancer cells, while binimetinib targets specific enzymes needed for cancer cell growth. Researchers hope that adding binimetinib will improve the effectiveness of the treatment by shrinking tumors and keeping them stable for a longer time.

Description

The study has two main goals: to see if the combination of fulvestrant and binimetinib can help patients live longer without their cancer getting worse, and to see if this combination can help patients whose cancer has already progressed on fulvestrant alone.

Participants are divided into two groups based on their previous treatment with fulvestrant.

  • Cohort I: Patients who have not been treated with fulvestrant before. They are randomly assigned to receive either fulvestrant alone or fulvestrant with binimetinib.
  • Cohort II: Patients whose cancer has progressed on fulvestrant. They receive the combination of fulvestrant and binimetinib.

The study will also look at the safety of the treatment, how long patients live overall, and collect tissue samples to study genetic changes in the cancer.

Participants will have regular scans and tests to monitor their health and the cancer's response to treatment. After completing the study treatment, patients will be followed up every six months for five years.

Eligibility Criteria

Inclusion Criteria

  • Must be part of the ComboMATCH study and have a specific genetic mutation.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of metastatic breast cancer that is hormone receptor-positive and HER2-negative.
  • Must have previously used a CDK4/6 inhibitor.
  • Must have good blood counts and organ function.
  • Must agree to provide a tumor sample for testing.
  • Must not have any other health conditions that would interfere with the study.
  • Women of childbearing potential must agree to use effective contraception during and after the study.

Exclusion Criteria

  • Cannot be receiving other cancer treatments at the same time.
  • Cannot have active autoimmune diseases requiring treatment.
  • Cannot have active brain metastases unless stable for at least one month.
  • Cannot have certain eye conditions or risk factors for eye problems.
  • Cannot have a history of heart problems unless stable.
  • Cannot be pregnant or breastfeeding during the study.
  • Cannot have used any investigational drugs within 30 days before the study.

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