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Studying Triple Negative Breast Cancer Using Orthotopic Breast Cancer Model
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A Phase II Trial of Selinexor (KPT-330) for Metastatic Triple-Negative Breast Cancer

Michael Shafique1, Roohi Ismail-Khan2, Martine Extermann3

  • 1Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA michael.shafique@moffitt.org.

The Oncologist
|April 19, 2019
PubMed
Abstract

Insights

Single-agent selinexor showed limited efficacy in patients with advanced triple-negative breast cancer. While well-tolerated, future research should explore combination therapies for this patient group.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Triple-negative breast cancer (TNBC) is an aggressive subtype with limited treatment options.
  • Selinexor, an oral selective inhibitor of nuclear export (SINE), targets XPO1, a key protein in cancer cell proliferation.

Purpose of the Study:

  • To evaluate the safety, pharmacodynamics, and efficacy of single-agent selinexor in patients with advanced TNBC.
  • To determine the clinical benefit rate (CBR) of selinexor in this population.

Main Methods:

  • A phase II trial enrolled 30 patients with metastatic TNBC.
  • Selinexor was administered orally at 60 mg twice weekly.
  • The primary endpoint was CBR, defined as the proportion of patients achieving complete response, partial response, or stable disease for at least 12 weeks.

Main Results:

  • Ten patients were enrolled; three achieved stable disease (SD), and seven had progressive disease.
  • The study was halted early based on predefined criteria.
  • Selinexor was generally well-tolerated, with a side-effect profile consistent with prior studies.

Conclusions:

  • Single-agent selinexor demonstrated limited activity in heavily pretreated TNBC patients.
  • A CBR of 30% was observed, suggesting potential but not definitive benefit.
  • Future studies should investigate selinexor in combination therapies and utilize biomarker-driven strategies for patient selection.

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