CT-P6 and Herceptin in Breast Cancer

• Research type

  Research Study

• Full title

  A Double-blind Randomised, Parallel Phase I/IIb Study to Evaluate Initial Safety and Efficacy, Comparative Pharmacokinetics and Immunogenicity for CT-P6 and Herceptin in Metastatic Breast Cancer

• IRAS ID

  46792

• Contact name

  Daniel William Rea

• Sponsor organisation

  Celltrion, Inc.

• Eudract number

  2009-014463-39

• ISRCTN Number

  n/a

• Research summary

  Breast cancer is the most common cancer among women. Each year more than one million new cases of breast cancer are diagnosed worldwide and despite advances in the treatment, a large percentage of women will have recurrence of the disease after initial treatment and develop metastases (cancer that spreads to other parts of the body). HER2-positive breast cancer is a type of cancer where increased quantities of the HER2 (Human Epidermal growth factor Receptor 2) protein are present on the surface of the tumour cells. This is known as ??HER2-positivity.?? The latest data indicate that 18% of new breast cancers are HER2-positive. The sponsor of the study is developing a new drug CT-P6 for the treatment of HER2 breast cancer. CT-P6 works in a similar way to Herceptin; a drug already licensed and used in the treatment of HER2 breast cancer. Both drugs are a type of targeted cancer therapy known as monoclonal antibodies. Antibodies are part of the body's normal defence against abnormal cells, such as cancer cells. Both drugs work by targeting the HER2 cell and stop the tumour from growing. This study is a double blind, randomised, study where patients will be allocated by chance (randomised) to one of the following groups ?½ CT-P6 plus Paclitaxel (an approved breast cancer treatment)?½ Herceptin plus Paclitaxel Both the patient and their doctor will not know which treatment they have been assigned to. The objectives are to evaluate pharmacokinetics (how the body processes the drug) and preliminary safety, efficacy and immunogenicity (production of antibodies) to the drugs of CT-P6 and Herceptin. Around 130 patients will be enrolled from 35 to 45 sites worldwide. Patients will undergo several tests during the study including: ?½ Safety Laboratory Assessments?½ Measurement of heart function?½ Imaging to assess the tumour

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  10/H1208/51

• Date of REC Opinion

  24 Aug 2010

• REC opinion

  Favourable Opinion