BO22589 T-DM1 +/- Pertuzumab vs Herceptin/Taxane in 1st Line MBC

• Research type

  Research Study

• Full title

  A randomised, 3 arm, multicentre, phase III study to evaluate the efficacy and the safety of T-DM1 combined with pertuzumab or T-DM1 combined with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab plus taxane, as first line treatment in HER2- positive progressive or recurrent locally advanced or metastatic breast cancer (MBC).

• IRAS ID

  42673

• Contact name

  Robert Coleman

• Sponsor organisation

  F Hoffmann La Roche AG

• Eudract number

  2009-017905-13

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Breast cancer is the most common cancer in women. In 2007, approximately 1.3 million women were diagnosed with breast cancer worldwide, and an estimated 465,000 breast cancer related deaths were expected. Approximately 100,000 of these breast cancer related deaths occur in patients that overexpress HER2 receptors. Metatastic Breast Cancer (MBC) is incurable, with the primary goal of treatment being to extend life and palliate symptoms while preserving quality of life. Overexpression of HER2 receptors is observed in 20% of human breast cancers. Several lines of scientific and clinical evidence support a direct role for HER2 overexpression in aggressive growth and poor clinical outcomes associated with these tumours. The development of Trastuzumab in the 1990's has provided women with HER2-overexpressing tumours with a better outcome than with chemotherapy alone. For patients with HER2 positive MBC, the combination of trastuzumab and a taxane is a globally accepted 1st line treatment option of choice based on the survival advantage demonstrated in two large pivotal trials (Studies H0468g and M77001). However, virtually all patients with HER2 positive MBC develop progressive disease (PD) and require additional therapies for palliation. T-DM1 is composed of the monoclonal antibody trastuzumab that delivers the linked chemotherapeutic agent (DM1) selectively to the ??HER2 positive? tumour cells. Pertuzumab is a monoclonal antibody that attaches to a different part of HER2 than trastuzumab, allowing these two drugs to act together in complementary ways. Both T-DM1 and pertuzumab are research drugs and are not yet registered for the treatment of breast cancer. Both T-DM1 and pertuzumab have been shown promising efficacy in a number of clinical studies. This study is designed to compare these new agents with the current standard treatment regimen. A total of 1092 patients will be randomised in approximately 350 sites worldwide.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  10/H0406/34

• Date of REC Opinion

  23 Jun 2010

• REC opinion

  Further Information Favourable Opinion