Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial)

Summary

This phase II ComboMATCH treatment trial compares the usual treatment alone (fulvestrant) to using binimetinib plus the usual treatment in patients with hormone receptor positive breast cancer that has spread from where it first started to other places in the body (metastatic) and has an NF1 genetic change. Fulvestrant is a hormonal therapy that binds to estrogen receptors in tumor cells, resulting in estrogen receptor destruction and decreased estrogen binding, which may inhibit the growth of estrogen-sensitive tumor cells. Binimetinib is a targeted therapy that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of binimetinib to fulvestrant in breast cancers with an NF1 genetic change could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to fulvestrant alone.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Metastatic HER2-Negative Breast Carcinoma
• Metastatic Hormone Receptor-Positive Breast Carcinoma

Interventions

DRUG

Binimetinib

Given PO

PROCEDURE

Biopsy Procedure

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT scan

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Fulvestrant

Given IM

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

Sponsors & Collaborators

• NRG Oncology

  collaborator OTHER

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Bora Lim · CenterThe University of Texas MD Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-13

Primary Completion

2025-04-04

Completion

2025-04-04

FDA Drug

Yes

Countries

• United States
• Puerto Rico

Study Locations