MO27775 PERTAIN Study

• Research type

  Research Study

• Full title

  A randomized, two-arm, open-label, multicenter Phase II trial assessing the efficacy and safety of pertuzumab given in combination with trastuzumab plus an aromatase inhibitor in first line patients with HER2-positive and hormone receptor-positive advanced (metastatic or locally advanced) breast cancer.

• IRAS ID

  88467

• Contact name

  Peter Schmid

• Sponsor organisation

  Roche products Limited

• Eudract number

  2011-002132-10

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study is to look at whether the time in which a patient with advanced breast cancer has without their breast cancer getting worse, is increased by adding a new drug called pertuzumab to treatment with trastuzumab and an aromatase inhibitor (AI). To enter the study patients must have a breast cancer that has too much of the HER2 protein on the surface. Suitable patients will be randomly allocated to get either trastuzumab AI or trastuzumab pertuzumab AI. Patients allocated to the pertuzumab treatment will have the pertuzumab as a drip into a vein in the arm, followed by the trastuzumab, given the same way on day 1 of each 3 week treatment cycle. The AI will be taken by mouth once every day. The other patients will have trastuzumab via a drip into a vein in their arm on day 1 of every 3 week treatment cycle, and the AI tablet every day. Treatment for all patients will continue until the signs of breast cancer return or if the side effects of the drugs become unacceptable. If the doctor decides that the patient will benefit from chemotherapy treatment first then these patients may be given a drug called a taxane (docetaxel every 3 weeks for up to 6 times or paclitaxel every week for up to 18 weeks). This will be given with the pertuzumab and trastuzumab or trastuzumab alone ?? depending which treatment the patient is allocated to. Patients having the chemotherapy treatment will not start their AI tablets until the chemotherapy has finished. The study will also find out if the side effects from each treatment are different or the same; it will also look at how the different treatments affect the patient??s ability to carry on with their everyday activities.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  11/LO/1921

• Date of REC Opinion

  28 Feb 2012

• REC opinion

  Further Information Favourable Opinion