Trastuzumab-MCC-DM1 in HER2-Positive Metastatic Breast Cancer

• Research type

  Research Study

• Full title

  A randomized, multicenter, phase II study of the efficacy and safety of trastuzumab-MCC-DM1 vs. trastuzumab (herceptin®) and docetaxel (taxotere®) in patients with metastatic her2-positive breast cancer who have not received prior chemotherapy for metastatic disease

• IRAS ID

  7805

• Sponsor organisation

  Genentech, Inc.

• Eudract number

  2008-002819-40

• ISRCTN Number

  n/a

• Research summary

  This is a clinical trial designed to: - explore the effectiveness and safety of T-DM1 compared with the combination of trastuzumab (Herceptin©) and docetaxel (Taxotere©) in patients with HER2-positive metastatic breast cancer (MBC) who have not received prior chemotherapy for metastatic disease. - characterise the pharmacokinetic (PK) properties of T-DM1 in this patient population. PK testing is done to assess the activity of drugs in the body over a period of time, including the processes by which drugs are absorbed, distributed, localised in the tissues, and excreted.T-DM1 is the drug that is being investigated in this study. It has not yet been approved for routine use by the regulatory authorities. The drug is produced by Genentech. It contains a chemotherapy linked to a laboratory produced protein (Herceptin©) that attaches to specific places on cancer cells, slowing the growth or killing the cancer cells. Clinical trials of T-DM1 have currently enrolled more than 100 women with MBC.Herceptin is a humanised monoclonal antibody also produced by Genentech. Antibodies are proteins that can protect the body from foreign invaders such as bacteria and viruses by binding to substances called antigens. Herceptin© is a monoclonal antibody to cancer cells and may be able to control tumour growth. It is approved by many health authorities around the world for the treatment of HER2-positive MBC.Docetaxel (Taxotere©; made by Aventis Pharmaceuticals Inc.) is a chemotherapy that has been approved by the European Medicines Agency (EMEA). Approximately 120 patients will take part in this study at around 25 study centres in the United States and 75 study centres in the rest of the world.This research study is sponsored by Genentech, Inc. SF US in the United States and F. Hoffmann La Roche Ltd. (Roche, Switzerland) in all other countries.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/8

• Date of REC Opinion

  18 Mar 2009

• REC opinion

  Further Information Favourable Opinion