Lapatax

• Research type

  Research Study

• Full title

  A phase I-II study of lapatinib and docetaxel as neoadjuvant treatment for HER-2 positive locally advanced/inflammatory or large operable breast cancer.

• IRAS ID

  65500

• Contact name

  David Cameron

• Sponsor organisation

  European Organisation for Research and Treatment of Cancer (EORTC)

• Eudract number

  2006-000864-94

• Clinicaltrials.gov Identifier

  NCT00450892

• Research summary

  This clinical trial has been set up for women diagnosed with breast cancer for which the recommended treatment is chemotherapy before the surgical procedure. Furthermore, their cancer cells were found to produce a specific protein on their membrane surface called ??HER 2? receptor, which means that this cancer is one of those for which Herceptin is a potential treatment. However effective Herceptin is, there is still a need to identify potentially better drugs to treat patients who have similar disease. One of these new drugs is called lapatinib which has been shown to work in breast cancers that are not responding to Herceptin. The overall study is divided into two different steps - A phase I study investigating on which dose of lapatinib can be combined safely with docetaxel. This part is now completed and is NOT the subject of this application. - A randomized phase II study. In the randomized study, the three different treatments are compared:* Lapatinib combined with docetaxel followed by FEC (Group 1) OR * Herceptin© combined with docetaxel followed by FEC (Group 2) OR * Lapatinib and Herceptin© combined with docetaxel followed by FEC (Group 3) FEC is a combination of three chemotherapy drugs (flurouracil, Epirubicin and Cyclophosphamide). FEC, docetaxel and Herceptin are registered drugs, which are widely used and have proven efficacy. The clinical trial will be conducted by the European Organization for Research and Treatment of Cancer (EORTC), but with support from the pharmaceutical company GlaxoSmithKline which makes the drug Lapitinib.

• REC name

  Scotland A REC

• REC reference

  11/SS/0020

• Date of REC Opinion

  16 Nov 2011

• REC opinion

  Further Information Favourable Opinion