A Phase 1b/2 Study of MEDI-573, with AI comparator in Breast Cancer

• Research type

  Research Study

• Full title

  A Phase 1b/2 Randomized Study of MEDI-573 in Combination with an Aromatase Inhibitor (AI) Versus AI Alone in Women with Metastatic Breast Cancer (MBC)

• IRAS ID

  79864

• Contact name

  Adrian Murray Brunt

• Sponsor organisation

  Medimmune LCC

• Eudract number

  2011-000198-29

• ISRCTN Number

  na

• Research summary

  This is a Phase 1b/2 Clinical Trial testing a new experimental drug, called MEDI-573, in adult postmenopausal females with a type of Breast Cancer called HR HER2-negative Metastatic Breast Cancer (MBC). This multicentre study to be conducted in many research sites around the World, is an open-label study, meaning that both the participants and the researchers will know which treatment the participants are receiving. This study is being done to find out what effects (good or bad) the combination of MEDI-573 and another kind of anticancer drug called an aromatase inhibitor (AI), have on this study population. Researchers will assess whether MEDI-573 is safe and tolerable, and will see whether it is effective as an anticancer treatment. This study also involves laboratory testing on tissue samples and blood samples to find out as much as possible on a biochemical/biological level about how MEDI-573 might affect this type of breast cancer.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  11/WM/0375

• Date of REC Opinion

  4 Jan 2012

• REC opinion

  Further Information Favourable Opinion