GO28509 PEGGY - Phase 2 study of GDC-0941 in metastatic breast cancer

• Research type

  Research Study

• Full title

  A Phase II, randomized study or paclitaxel with GDC-0941 versus paclitaxel with placebo in patients with locally recurrent or metastatic breast cancer

• IRAS ID

  117736

• Contact name

  Peter Schmid

• Sponsor organisation

  Genentech, Inc.

• Eudract number

  2012-003262-41

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study will recruit 180 patients, aged 18 and over, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) negative subtype of breast cancer that has returned after it was treated or that had already spread to other parts of the body at diagnosis. HER2 is a protein found on the surface of certain cancer cells that can affect growth of the cancer. If a patient's tumour is HER2-negative, it is not amenable to some treatments. Approximately 85 sites will take part around the world. The purpose of the study is to find out how great the benefit of a drug, GDC 0941, is on participants when given together with another drug, paclitaxel, that is used to treat breast cancer patients. Also included is a biomarker component to find out if patients whose tumours have a certain mutation may derive more benefit from this treatment. GDC-0941 is an experimental drug that inhibits a protein called PI3-kinase that may be involved in the growth and spread of some cancers and has been implicated in resistance to cancer treatment. In animal studies and laboratory experiments, GDC-0941 has been shown to prevent or slow the growth of many different types of human cancer cells. Despite improvements in treatment outcomes for patients with this type of cancer, the disease remains therapeutically challenging. Consenting patients will be randomly placed into one of two treatment groups. One will receive paclitaxel in combination with GDC-0941. The other will receive paclitaxel with placebo. A placebo is an inactive substance that looks like GDC-0941 but has not active medical ingredient alone or when added to another medicine, such as paclitaxel. Patients will be treated until the disease worsens, treatment-limiting toxicity, or death due to any cause.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  13/LO/0033

• Date of REC Opinion

  20 Jan 2013

• REC opinion

  Favourable Opinion