A Phase II study of olaparib in breast cancer patients: biological evaluation from a 'window of opportunity' trial

Future Oncol. 2016 Oct;12(19):2189-93. doi: 10.2217/fon-2016-0116. Epub 2016 Jun 21.

Abstract

The OLTRE trial (ClinicalTrials.gov number: NCT02681562) is an open-label, 'window of opportunity' Phase II controlled trial to evaluate the biological activity of olaparib in locally advanced triple-negative breast cancer compared with other subtypes of locally advanced breast cancer patients carrying germinal BRCA mutation receiving olaparib with the same treatment approach. The primary end point is to investigate the correlation between baseline gene and protein expression profile in order to identify possible predictive markers of response to olaparib. The OLTRE trial is expected to identify the surrogate markers of the biological activity of olaparib in the treatment of patients with triple-negative breast cancer.

Keywords: BRCA; olaparib; triple-negative breast cancer.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Breast Neoplasms / diagnosis
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / mortality
  • Drug Administration Schedule
  • Female
  • Humans
  • Molecular Targeted Therapy
  • Neoplasm Staging
  • Phthalazines / administration & dosage
  • Phthalazines / adverse effects
  • Phthalazines / therapeutic use*
  • Piperazines / administration & dosage
  • Piperazines / adverse effects
  • Piperazines / therapeutic use*
  • Poly(ADP-ribose) Polymerase Inhibitors / administration & dosage
  • Poly(ADP-ribose) Polymerase Inhibitors / adverse effects
  • Poly(ADP-ribose) Polymerase Inhibitors / therapeutic use*
  • Treatment Outcome
  • Triple Negative Breast Neoplasms / diagnosis
  • Triple Negative Breast Neoplasms / drug therapy
  • Triple Negative Breast Neoplasms / mortality

Substances

  • Antineoplastic Agents
  • Phthalazines
  • Piperazines
  • Poly(ADP-ribose) Polymerase Inhibitors
  • olaparib

Associated data

  • ClinicalTrials.gov/NCT02681562