GO25632-Phase 3 study for treatment of metastatic breast cancer

• Research type

  Research Study

• Full title

  A Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Bevacizumab, and associated biomarkers, in combination with Paclitaxel compared with Paclitaxel plus placebo as first-line treatment of patients with HER2-negative metastatic breast cancer

• IRAS ID

  102736

• Contact name

  David Miles

• Sponsor organisation

  Genentech Inc.

• Eudract number

  2011-005335-97

• ISRCTN Number

  n/a

• Research summary

  This is a Phase 3 study to find out whether Bevacizumab (a licensed drug) is safe and effective when used together with Paclitaxel (a non-investigational medicinal product) to treat patients with HER2-negative metastatic breast cancer. HER2 (human epidermal growth factor receptor 2) is a protein found on the surface of certain cancer cells that can affect the growth of the cancer. If a patient's tumour is HER2-negative, it is not amenable to treatments such as herceptin. Vascular endothelial growth factor (VEGF) levels will be determined at screening. Bevacizumab is an antibody which binds to, and inhibits VEGF. VEGF stimulates formation of blood vessels that contribute to the growth and spread of cancer. Solid cancers cannot grow beyond a limited size without an adequate blood supply; cancers that can express VEGF are able to grow and metastasize (spread). The aim of this study is to confirm the findings of a previous study of bevacizumab in breast cancer (E2100) and also to determine whether patients with high baseline levels of VEGF derive greater benefit following treatment with bevacizumab. Treatment with Bevacizumab and Paclitaxel will be compared to treatment with Paclitaxel and placebo (medicine that looks the same as Bevacizumab but contains no active ingredient). Patients will be randomly assigned to one of the two treatment groups. The study is double-blind, meaning that neither the study doctor nor the patient will know which treatment he/she is receiving. Patients will be treated until the disease worsens, treatment-limiting toxicity, or death due to any cause. Approximately 480 patients with previously untreated, locally recurrent or metastatic HER2-negative breast cancer will be enrolled globally at approximately 200 centres.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  12/LO/1081

• Date of REC Opinion

  14 Sep 2012

• REC opinion

  Further Information Favourable Opinion