BKM120 / Placebo + Paclitaxel in HER2 negative breast cancer patients

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo controlled, phase II study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without PI3K pathway activation.

• IRAS ID

  105606

• Contact name

  Iain MacPherson

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-005932-24

• Research summary

  The purpose of the study is to assess the safety and eficacy of BKM120 given daily in combination with paclitaxel compared to giving paclitaxel alone in adult female patients with inoperable locally advanced or metastatic HER2 negative Breast Cancer not previously treated by chemotherapy in this setting. The new drug acts by interfering with proteins called PI3Kinases and PTEN which have been shown to be involved in the growth and survival of cancer cells in the laboratory. BKM120 is developed and manufactured by the company Novartis Pharmaceuticals, it is experimental and therefore only available for use in clinical trials. Patients will have their tumour samples (archival or fresh)tested for the activation of the PI3 kinase, PTEN and hormone receptor status. This will help determine whether patients with specific hormone receptor status's and PI3K activation pathways in their tumours respond better to treatment with BKM120. Randomisation will be stratified according to PI3K activation status (PI3 Kinase pathway activated vs. PI3 Kinase pathway non-activated) and hormone receptor (HR) status (positive vs.neagtive). Patient will receive in a 1:1 ratio either BKM120 daily Paclitaxel weekly or Placebo daily Paclitaxel weekly. There will be 200 patients enrolled into the study.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  12/ES/0049

• Date of REC Opinion

  4 Jul 2012

• REC opinion

  Further Information Favourable Opinion