PRESENT

• Research type

  Research Study

• Full title

  Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment (PRESENT)

• IRAS ID

  114646

• Contact name

  Mary O'Brien

• Sponsor organisation

  Galena Biopharma, Inc

• Eudract number

  2011-005219-98

• Clinicaltrials.gov Identifier

  NCT01479244

• Research summary

  It is known that following standard treatment for breast cancer, many women have lone cancer cells remaining in their body undetected by scans or screening tests that will grow into metastatic disease in the future. NeuVax?½ is an immunotherapy vaccine that has been developed to help the body??s immune system to recognize and destroy these lone cancer cells.This is a multicenter, multinational, randomized, double-blind, study to assess the safety of NeuVax?½ and how well it works in patients with early stage node positive breast cancer whose tumors have low or intermediate levels of the HER2 protein. NeuVax?½ is a peptide vaccine developed for use in patients that have completed all of the standard treatment (except hormone treatment which may be given at the same time as NeuVax) Patients will either receive the NeuVax vaccine, containing study peptide plus GMCSF (a growth factor to encourage the immune system) or a control vaccine containing GMCSF only.This study will compare the outcomes for both groups of patients by measuring and comparing Disease Free Survival, Overall Survival, 5- and 10-year Disease Free Survival and Overall Survival, time to recurrence, and safety of the vaccine.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  13/LO/0021

• Date of REC Opinion

  25 Feb 2013

• REC opinion

  Further Information Favourable Opinion