Trastuzumab emtansine in combination with atezolizumab in HER2+ non-op

• Research type

  Research Study

• Full title

  A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II STUDY OF THE EFFICACY AND SAFETY OF TRASTUZUMAB EMTANSINE IN COMBINATION WITH ATEZOLIZUMAB OR ATEZOLIZUMAB-PLACEBO IN PATIENTS WITH HER2-POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE RECEIVED PRIOR TRASTUZUMAB AND TAXANE BASED THERAPY.

• IRAS ID

  208246

• Contact name

  Mark Beresford

• Contact email

  mark.beresford@nhs.net

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2015-004189-27

• Duration of Study in the UK

  2 years, 8 months, 0 days

• Research summary

  The purpose of this study is to find out what effects, good or bad, atezolizumab has on the patient and their cancer when combined with trastuzumab emtansine. Trastuzumab emtansine is a drug that combines trastuzumab [a man-made antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer) that attaches to HER2 on the surface of cancer cells] and a chemotherapy drug (DM1).
  Trastuzumab emtansine (Kadcyla®) has been approved by the U.S. FDA for the treatment of HER2-positive metastatic breast cancer.
  Atezolizumab is a man-made antibody (a protein produced by the body's immune system) that affects the immune system by blocking the programmed deathligand 1 (PD-L1) pathway. The PD-L1 pathway is involved in regulating the body’s natural immune response, but tumors can take advantage of this regulation to partially resist or evade the immune system. By blocking the PD L1 pathway, atezolizumab may help the patients immune system to stop or reverse the growth of tumors.
  Health authorities have not yet approved treatment with atezolizumab for breast cancer.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  16/EM/0320

• Date of REC Opinion

  31 Aug 2016

• REC opinion

  Further Information Favourable Opinion