MO28231 T-DM1 Safety Study

• Research type

  Research Study

• Full title

  A two-cohort- open-label, multicenter, study of trastuzumab emtansine (T-DM1) in HER2- positive locally advanced or metastatic breast cancer patients who have received prior anti-HER2 and chemotherapy-based treatment

• IRAS ID

  109645

• Contact name

  Paul Ellis

• Eudract number

  2012-001628-37

• Research summary

  This study is looking for male and female patients with locally advanced cancer (cancer that has spread into tissue surrounding the breast) or metastatic breast cancer (cancer that has spread to other parts of your body or come back at the same place). To enter the study patients must have a breast cancer that has a type of protein called HER2 on its surface. This type of breast cancer is known as HER2 positive. It looking at how safe (the number and type of side effects) and how effective a new medicine is for the treatment of this type of cancer. The drug, called T-DM1 or trastusumab emtasine, is a new type of cancer drug called an antibody drug conjugate (ADC). It is made up of three parts; Herceptin© (trastuzumab), a drug used routinely for patients with HER2 positive breast cancer, a cytotoxic drug (one that stops cancer cells from growing) called DM1, and a linker which joins the Herceptin to the DM1. This new drug is designed to target only HER2 positive cancer cells which it binds to. It is then taken inside the cell where the cytotoxic part of the drug (DM1) is released. Trastuzumab emtansine is not given in combination with chemotherapy. All patients will receive trastuzumab emtansine as an infusion into the vein. The first infusion will be given over 90 minutes and the patient will be observed for at least 90 minutes afterwards. Providing there are no problems, subsequent infusions will be given over 30 minutes and the patient will be observed for at least 30 minutes afterwards. Suitable patients will be given this new antibody drug conjugate until their disease progresses (gets worse), the side effects of the drug become unacceptable, or they decide they no longer want to take part. Safety assessments, will be done regularly.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  12/LO/1351

• Date of REC Opinion

  8 Oct 2012

• REC opinion

  Further Information Favourable Opinion