Denosumab as Adjuvant Treatment for Early-Stage Breast Cancer (D-CARE)

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence (D-CARE)

• IRAS ID

  47668

• Contact name

  Robert Coleman

• Sponsor organisation

  Amgen Inc.

• Eudract number

  2009-011299-32

• Research summary

  Subjects who will be asked to consider taking part in this study are patients with early-stage breast cancer at high risk of the cancer coming back. The purpose of this research study is to find out how safe and effective denosumab is, in preventing or delaying the time it takes for cancer to spread to the bones. The expected time that treatment would be received on this study is about 60 months or 5 years. The patient's condition would also be followed for approximately an additional 60 months or 5 years after the end of the study treatment. However, the study doctor would assess the patient's response to the study treatment and the participation may be longer or shorter than the estimated time. Patients will be randomised into two groups, where one will receive a dummy drug treatment, with no active ingredients in and the other will receive the active drug Denosumab. Both treatment groups will receive other treatment (e.g. chemotherapy) for the treatment of their cancer. Neither patient nor study doctor will know which treatment group the patient is in.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  10/H1002/27

• Date of REC Opinion

  3 Jun 2010

• REC opinion

  Favourable Opinion