PLANET

• Research type

  Research Study

• Full title

  A randomised Phase II study of carboplatin with or without the addition of the ETAR inhibitor ZD4054 as treatment for patients with metastatic breast cancer.

• IRAS ID

  51630

• Contact name

  Colin James

• Contact email

  Colin.James.covance.com

• Eudract number

  2010-018837-23

• ISRCTN Number

  ISRCTN73466214

• Clinicaltrials.gov Identifier

  NCT01134497

• Research summary

  The prognosis for patients with metastatic breast cancer is poor. Once it has spread to other parts of the body, breast cancer is incurable, with women living, on average, a further 24 months. The aims when treating women with metastatic breast cancer are to prolong and improve their day to day life. The aim of this trial is to use a new drug called ZD4054 combined with an established chemotherapy drug (carboplatin) to see whether this prolongs the period for which women live with the cancer kept under control. ZD4054 is a new, oral drug developed by AstraZeneca which may help to slow down cancer growth. It works by blocking growth that is controlled by specific proteins on cancer cells called endothelins. In this ??randomised Phase II trial? all women will receive carboplatin, with half randomly selected to receive ZD4054 and the other half to receive a dummy pill or placebo. The trial will recruit up to 132 women with metastatic breast cancer from across the UK and assess whether adding ZD4054 to carboplatin delays progression of their disease. It will also show whether the side effects of adding ZD4054 to carboplatin chemotherapy are acceptable. Because ZD4054 has not previously been given with carboplatin to this population, in stage 1 of the study 3 women will receive ZD4054 and carboplatin to ensure there are no unexpected side effects. If there are no untoward side effects a further 3 patients will receive ZD4054 with carboplatin. If there are no untoward side effects with full dose carboplatin and ZD4054 the trial will proceed to stage 2 and a further 126 patients will be randomised to receive carboplatin with either ZD4054 or the placebo.

• REC name

  Wales REC 3

• REC reference

  10/MRE09/33

• Date of REC Opinion

  24 Nov 2010

• REC opinion

  Further Information Favourable Opinion