EAY191-N2

Phase 2 Trial of Fulvestrant and Binimetinib in Patients with Hormone Receptor-Positive Metastatic Breast Cancer with Inactivating or Inferred Inactivating NF1 Alterations: A ComboMATCH Treatment Trial

Principal Investigator

Bora Lim

Status

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 in
patients 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 fulvestrant
and 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