Biological activity of R1507 in women with operable breast cancer

• Research type

  Research Study

• Full title

  An exploratory study to evaluate the biological activity of R1507, a human monoclonal antibody antagonist of the insulin-like growth factor receptor (IGF-1R) in women with operable breast cancer

• IRAS ID

  7138

• Contact name

  J Michael Dixon

• Sponsor organisation

  F.Hoffmann-La Roche

• Eudract number

  2008-004128-22

• Research summary

  This is a study which looks at how the drug (R1507) affects breast cancer cells in women with operable breast cancer. Female patients with suspected breast cancer will have a diagnostic biopsy, if they are found to have operable breast cancer they will be asked to join the study. They will receive 1 dose of drug and when they have their planned surgery to remove the breast cancer one week later skin and breast cancer tissue samples will be taken. The blood and tissue samples from a screening visit will be compared to the blood and tissue samples taken during the surgery to see if the drug has affected the cancer. This will help find out what the best and safest dose is for women to receive for breast cancer treatment, it will also help future clinical trials of this drug.We will also compare the levels of drug in the patients to see any effects the drug has on tumour tissue.

• REC name

  Scotland A REC

• REC reference

  09/MRE00/13

• Date of REC Opinion

  8 Apr 2009

• REC opinion

  Further Information Favourable Opinion