IPET version 1.0 27.01.2012

• Research type

  Research Study

• Full title

  A phase II, open label, preoperative study to assess the efficacy of the novel steroid sulfatase inhibitor Irosustat in postmenopausal women with early oestrogen receptor positive breast cancer.

• IRAS ID

  89069

• Contact name

  Carlo Palmieri

• Sponsor organisation

  Imperial College London

• Eudract number

  2011-005240-10

• Research summary

  This study is investigating the effects of a new hormone treatment for breast cancer called Irosustat. 70% of breast cancers that occur in postmenopausal women rely on the hormone oestrogen to grow. These are so called hormone sensitive breast cancers and are likely to respond to hormone treatment. Irosustat blocks one of the pathways involved in the synthesis of oestrogen, reducing in this way oestrogen levels in the body. As less oestrogen reaches the breast cancer, it grows more slowly or stops growing altogether. Postmenopausal women with early, hormone sensitive, treatment naive breast cancer will receive 40mg of Irosustat once daily for 2 weeks. The effects of Irosustat on breast cancer will be evaluated by PET scans (Positron Emission Tomography) using a radioactive substance called FLT as a tracer. The scans will be performed in a PET-CT scanner which combines a PET scan and a CT scan (Computer Tomography) into one scan. This type of scan can show how body tissues are working, as well as what they look like. Because cancer cells grow faster than the normal cells around them, they will take up more of the radioactive substance, and so stand out clearly on the scan. If Irosustat is slowing down the cancer growth, the cancer will take up less of the tracer. FLT-PET scans will be performed before and after treatment with Irosustat. Blood samples will be taken at regular intervals to assess what the new drug does to the body. Researchers will combine pictures of the breast cancer along with the results of the blood tests to see how the treatment has affected its growth. Participating patients will also be given the option to take part in the exploratory part of this study by donating tissue samples from their breast cancer.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  12/LO/0269

• Date of REC Opinion

  27 Apr 2012

• REC opinion

  Further Information Favourable Opinion