Peruse: Global safety study with pertuzumab in Her2+ advanced BC

• Research type

  Research Study

• Full title

  A Multicentre, Open-label, Single-arm Study of Pertuzumab in Combination with Trastuzumab and a Taxane in First Line Treatment with Her2-Postive Advanced (Metastatic or Locally Advanced Recurrent) Breast Cancer

• IRAS ID

  97442

• Contact name

  David Miles

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2011-005334-20

• Duration of Study in the UK

  4 years, 0 months, 0 days

• Research summary

  This study is looking for male and female patients with advanced 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 protein called HER2 present on the surface of its cells.

  The study will investigate the effect of adding an experimental medicine called pertuzumab to a current well used combination of Herceptin® (trastuzumab) plus a taxane (a type of chemotherapy). Pertuzumab acts on the same HER2 protein on the breast cancer cells as Herceptin® but acts in a different way. The study will look at the number and type of side effects experienced by patients on the study, as well as how effective the treatment is.

  All patients will receive the same treatment of pertuzumab and Herceptin® plus a taxane. Patients will be given pertuzumab as a drip in to a vein (iv infusion) on their arm, followed by Herceptin®, given the same way on day 1 of each 3 week treatment cycle. The taxane will be given after the pertuzumab and Herceptin®, according to the approved treatment schedule for that drug. The choice of taxane will be made by the patient’s study doctor, based on what is most suitable for the patient’s situation.

  Patients will receive the study treatment until their disease gets worse (progresses), they have unacceptable side effect or they decide they no longer want to take part. Safety assessments, including blood and heart tests, will be done regularly while on treatment and at a follow-up visit 28 days after the end of study treatment. Patients will then be followed up every 3 months, for at least a year.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/0482

• Date of REC Opinion

  23 Apr 2012

• REC opinion

  Favourable Opinion