EAY191-N2

EAY191-N2: Phase 2 Trial of Fulvestrant and Binimetinib in Patients With Hormone Receptor-Positive Metastatic Breast Cancer With a Frameshift or Nonsense Mutation or Genomic Deletion in NF1

Principal Investigator

Bora Lim, MD

Status

Open to Accrual

Disease Site

Breast [BR]

Breast

Phase

II

Developmental Therapeutics

No

Primary Objective

Cohort 1: To determine whether the combination of fulvestrant and binimetinib improves PFS compared to treatment with fulvestrant alone inpatients not previously treated with fulvestrant.

Cohort 2: To determine whether ORR within 4 months in patients who have previously progressed on a fulvestrant-containing regimen is greater than 10%,as a historical comparison, when these patients receive combination fulvestrantand binimetinib therapy.

Patient Population

Patients with metastatic hormone receptor-positive HER2-negative breast cancers with a non-functional mutation in the NF1 gene.

Target Accrual

95