BEACON Study: Breast Cancer Outcomes With NKTR-102 (11-PIR-11)

• Research type

  Research Study

• Full title

  The BEACON Study (BrEAst Cancer Outcomes with NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment of Physician’s Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, a Taxane, and Capecitabine

• IRAS ID

  101525

• Contact name

  Christopher Twelves

• Sponsor organisation

  Nektar Therapeutics

• Eudract number

  2011-003832-30

• Clinicaltrials.gov Identifier

  NCT01492101

• Research summary

  This international Phase 3, open-label randomised study is funded by Nektar Therapeutics, a biopharmaceutical company in San Francisco, California. The research aims to establish whether the study drug, NKTR-102, given by intravenous infusion (IV), compared with standard treatments for breast cancer also called ??treatments of physician??s choice (TPC)?, is safe and effective. This study will look at how patients with locally recurrent or metastatic breast cancer (MBC) previously treated with at least two and a maximum of five prior cytotoxic chemotherapy regimens including an anthracycline, a taxane, and capecitabine (ATC), respond to NKTR-102 or TPC. In some patients, optional biomarker and pharmacokinetic (PK) studies will measure the number of tumour cells in the body and how long NKTR-102 stays in the blood. There is currently no standard of care or universal chemotherapeutic approach for treating patients with MBC who have failed treatment with ATC. Choice of chemotherapeutic agent is decided by the nature and timing of prior therapy, extent of disease burden, cancer-related symptoms, patient preference and the availability of specific drugs in a given country. The primary goal of this study is to determine whether NKTR-102 prolongs overall survival in these patients compared with TPC. Approximately 840 female patients aged 18 and over will take part in this study and will be enrolled in the study for up to 38 months. Time in this study will be counted in treatment cycles. The number of days patients can take part in the study depends on the side effects they have, and whether their cancer responds to the study treatment. The study doctor will assess the patients?? ability to continue participation. The study will take place in approximately 200 study sites, in 15 countries, throughout the world including North America, Europe and Asia.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  12/EE/0178

• Date of REC Opinion

  15 Jun 2012

• REC opinion

  Further Information Favourable Opinion