OAM4861g:MetMab vs placebo in metatastic triple-negative breast cancer

• Research type

  Research Study

• Full title

  A randomized, phase II, multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of MetMab in combination with paclitaxel and bevacizumab in patients with metastatic, triple-negative breast cancer.

• IRAS ID

  57952

• Contact name

  Peter Schmid

• Sponsor organisation

  Genentech Inc

• Eudract number

  2010-020101-32

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Metastatic (cancer which has spread throughout the body) breast cancer is the most common invasive cancer in women, and the second most common cause of cancer death in women. The triple-negative sub-type of breast cancer has the poorest prognosis. There is a significant need to develop new therapies for this subtype. The investigational drug from Genentech (the study sponsor) in this study is called MetMab; it is a monoclonal antibody (a type of protein normally made by the immune system to fight infection). MetMAb binds to the Met receptor, a specific site on cells that is thought to be important in cancer growth; MetMAb prevents Met from activating tumour cells. MetMab has been tested in animals and has shown that it slows the growth of different types of human cancer cells grown in animals.In this study, MetMAb will be used with bevacizumab and paclitaxel (a chemotherapy drug approved for use in breast cancer); bevacizumab is also an experimental drug from Genentech; the European Medicines Agency has approved bevacizumab plus paclitaxel for use in breast cancer. This is a double-blind placebo controlled trial to see if MetMab bevacizumab paclitaxel (compared with bevacizumab paclitaxel) is safe and effective when given to patients with triple-negative breast cancer . Approximately 120 participants will take part in this study at about 30 centres in the US and Europe including the UK.The study has a screening period of 28 days followed by a treatment period of 24 months. Study treatment will be given in cycles repeated every 28 days. Study procedures include physical examinations, blood tests, ECGs and CT scans. After the last dose of study treatment, follow-up contacts will be made every 3 months.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  10/H0703/69

• Date of REC Opinion

  3 Nov 2010

• REC opinion

  Further Information Favourable Opinion