Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer

Open Label, Uncontrolled, Study of XRP9881 (Larotaxel) in Combination With Weekly Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)

The purpose of this study is to evaluate the anti-tumor activity of the combination of experimental drug (larotaxel) when combined with Herceptin® in patients with advanced breast cancer. Anti-tumor activity will be determined by looking at changes in tumor size on CT or MRI scans. Additional goals of this study are to look at patient safety, to determine how long the study drugs (larotaxel and Herceptin®) stay in the patient's body and what effects the study medications may have on each other, and to find out how long patients remain cancer free on this study treatment.

Inclusion Criteria:

• Diagnosis of breast cancer
• Evidence that cancer has spread beyond its original location or has come back and cannot be removed by surgery
• No more than one prior treatment for advanced disease
• Her2 positive status
• Adequate liver and kidney function
• No remaining severe harmful effects to prior treatments

Exclusion Criteria:

• Certain heart condition
• Pregnant Women
• History of another cancer except some skin cancers and cervical cancer
• Taking other treatments for your cancer at the time you enter the trial