EPIK-B2:Ph III study with BY719 in aBC HER2+ and PI3KC mut

• Research type

  Research Study

• Full title

  EPIK-B2: A two part, Phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with trastuzumab and pertuzumab as maintenance therapy in patients with HER2-positive advanced breast cancer with a PIK3CA mutation

• IRAS ID

  279257

• Contact name

  Karen McAdam

• Contact email

  kmcadam@nhs.net

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2019-002741-37

• Clinicaltrials.gov Identifier

  NCT04208178

• Duration of Study in the UK

  9 years, 7 months, 8 days

• Research summary

  The purpose of this two-part study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment following induction therapy in patients with HER2-positive advanced breast cancer with a PIK3CA mutation. The open-label, safety run-in part of the study that will confirm the recommended phase 3 dose (RP3D) dose of alpelisib in combination with trastuzumab and pertuzumab, will be conducted prior to the Phase III part of the study.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  20/LO/0565

• Date of REC Opinion

  26 May 2020

• REC opinion

  Further Information Favourable Opinion