ML22780 Advanced Triple Negative Study

• Research type

  Research Study

• Full title

  Open-label study of bevacizumab (Avastin) and taxane monotherapy for the first-line treatment of patients with advanced triple negative breast cancer

• IRAS ID

  26337

• Contact name

  Catherine Bale

• Sponsor organisation

  Roche Products Ltd

• Eudract number

  2009-014279-37

• Research summary

  So-called triple-negative breast cancer (cancers which lack both receptors for the female hormones and the HER2 receptor), tends to have an aggressive growth pattern. This includes early development of secondary tumours and rapid regrowth of the cancer after therapy, leading to a short survival time for patients with this form of the disease. Because of the lack of receptors, triple-negative breast cancer does not respond to the main forms of targeted therapy, namely anti-hormonal agents (e.g.tamoxifen) and anti-HER2 agents (e.g.trastuzumab). As a consequence, patients with this form of breast cancer have a limited choice of therapies and are poorly served by current treatment options. New therapies for treatment of this type of breast cancer are urgently needed.Bevacizumab belongs to a novel class of anticancer agent, which target the blood supply that's essential for the growth of all solid tumours. It is the first agent of this type to be licensed for use in metastatic (advanced) breast cancer. In Phase III studies where it was combined with taxane therapy, bevacizumab gave a significant increase in the proportion of patients showing tumour shrinkage and a significant extension of the time before treated tumours regrew, compared with taxanes alone. Generally, bevacizumab was well tolerated and its side effects were limited and readily manageable. The purpose of the current study is to assess the safety, patient tolerability and efficacy of bevacizumab combined with taxane therapy in routine UK hospital practice, in patients with triple negative breast cancer. The study will also generate economic data for the costs of using bevacizumab in NHS centres. This will demonstrate whether this combination therapy can be readily used in routine UK practice and whether it provides significant benefit within the NHS, for patients with this particularly malign form of the disease.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  09/H1002/80

• Date of REC Opinion

  7 Dec 2009

• REC opinion

  Further Information Favourable Opinion