( rom this study have enabledus to make ...)Investigational Cancer Drug Pertuzumab Shows Promising Results in,Advanced Breast Cancer When Combined with Herceptin,Health

rom this study have enabled us to make the decision to progress to phase III development of pertuzumab in breast cancer," commented Jean-Jacques Garaud, Head of Development, Roche. "We will be investigating the effectiveness of pertuzumab in the metastatic setting and also exploring its use in early breast cancer prior to surgical removal of the tumour."

About the study This is a non-randomised Phase II study, conducted in two-stages: patients were assessed to ensure that the therapy is tolerable and that there is a reasonable minimum level of activity. Eligible patients must have measurable, centrally-tested progressive HER2 positive breast cancer and had received up to 3 courses of prior chemotherapy plus Herceptin and the disease must have progressed during Herceptin therapy . During the study patients received Herceptin i.v weekly or every 3 weeks at 2 mg/kg or 6 mg/kg respectively and 420mg of pertuzumab i.v. every 3 weeks after a loading dose of 840mg. The criteria to proceed to the 2nd stage were: > 2 partial responses (PR), or 1 PR and 12 patients with stable disease (SD), or 13 patients with SD.

Out of 33 patients who had passed the first assessment point at the time of the data cut off, 1 had a complete response and 5 had partial responses giving a response rate of 18.2%. A further 7 patients have had stabilization of disease lasting 6 months or more (21.2%). Recruitment into stage 2 of the trial is ongoing.

As well as evaluating pertuzumab in breast cancer Roche and Genentech are evaluating pertuzumab in ovarian cancer in combination with other therapies. Results from a phase II platinum resistant ovarian cancer study will be presented at ASCO on Sunday 3rd June 1-4pm.

About breast cancer Breast cancer is the most common cancer among women worldwide (2). Each year more than one million new cases of breast cancer are diagnosed worldwide, and nearly 400,000 people will die of the disease annually. In HER2-positive breast cancer,
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