BO22280 Pertuzumab + Trastuzumab in HER2+ Early BC (NeoAdjuvant)

• Research type

  Research Study

• Full title

  A randomised, multicentre, multinational Phase II study to evaluate pertuzumab in combination with trastuzumab given either concomitantly or sequentially with standard anthracycline based chemotherapy or concomitantly with a non-anthracycline based chemotherapy regimen, as neoadjuvant therapy for patients with locally advanced, inflammatory or early stage HER2-positive breast cancer

• IRAS ID

  27700

• Sponsor organisation

  F Hoffman-La Roche Ltd

• Eudract number

  2009-012019-17

• ISRCTN Number

  n/a

• Research summary

  Breast cancer is the most common cancer in women. Each year, approximately 100,000 of breast cancer related deaths occur in patients that overexpress HER2 receptors. In the 1990??s Trastuzumab provided women who had HER2-overexpressing tumours with a better outcome than with chemotherapy alone. Pertuzumab is a monoclonal antibody and, like Trastuzumab, binds to the HER2 protein. Because Pertuzumab and Trastuzumab bind to different regions of the HER2 protein their modes of action are different, yet complimentary. Indeed, Pertuzumab may increase the level of activity seen with Trastuzumab in HER2 overexpressing tumours. This combination has become of interest following clinical evidence demonstrating the combination is both active and well tolerated in carefully selected patients (1, 2). The data is consistent with other data concerning the use of combined biological therapies. Anthracyclines, Taxanes and Carboplatin each have a central role in the management of breast cancer. In various combinations, these agents are in current use for the treatment of early breast cancer (Neoadjuvant therapy). Overall this study will add to the knowledge of the risk and benefit associated with the addition of pertuzumab to common chemotherapy regimens used in breast cancer which is HER2 positive and could eventually lead to further studies of pertuzumab in patients with early (and potentially curable) breast cancer. For patients who volunteer to participate in the study, it will provide an opportunity to receive a promising new agent in addition to standard Neoadjuvant treatment. 1 Baselga J, et al. (2007). Proceedings of the American Society of Clinical Oncology 2007, abstract number 1004 2 Gelmon K et al (2008). Proceedings of the American Society of Oncology 2008, abstract number 1026.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  09/H0504/106

• Date of REC Opinion

  17 Sep 2009

• REC opinion

  Further Information Favourable Opinion