ARTemis

• Research type

  Research Study

• Full title

  ARTemis: Avastin Randomised Trial with neo-adjuvant chemotherapy for patients with early HER2-negative breast cancer.

• IRAS ID

  7380

• Contact name

  Helena Earl

• Sponsor organisation

  Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

• Eudract number

  2008-002322-11

• ISRCTN Number

  N/A

• Research summary

  Bevacizumab (Avastin) is a monoclonal antibody treatment which can inhibit the development of new blood vessels which are necessary for cancer growth. This will reduce the cancer's supply of oxygen and starve it of nutrients, causing the tumour to shrink, or stop growing. Bevacizumab therefore belongs to the family of drugs known as 'angiogenesis inhibitors' i.e. these are drugs which stop tumours making new blood vessels.The objective of the ARTemis trial is to find out whether bevacizumab helps to improve response rates in patients diagnosed with early breast cancer given standard chemotherapy.The ARTemis trial is recruiting patients with early breast cancer, to receive treatment before surgery on the breast, known as neoadjuvant therapy. In this trial we will be finding out whether adding a short course of bevacizumab (4 x 3 weekly cycles) to standard neoadjuvant chemotherapy treatment (6 cycles of treatment) improves the outcome for patients. The trial has a prospective, randomised design, with half of the patients receiving bevacizumab (4 cycles) at the same time as chemotherapy (docetaxel x 3 cycles followed by FEC x 3 cycles), and half the patients receiving chemotherapy alone (6 cycles).Patients will have early breast cancer, and the tumours will be HER2 negative, and either oestrogen receptor (ER) positive or negative. A total of 800 patients will be recruited in this multi-centre national trial. The endpoint is the response in the tumour under the microscope (pathological response) at the time of surgery to remove the primary tumour after the course of treatment.

• REC name

  London - South East Research Ethics Committee

• REC reference

  08/H1102/104

• Date of REC Opinion

  19 Nov 2008

• REC opinion

  Favourable Opinion