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7 Jun 2013

Breast cancer drug to enter phase 3 clinical trial

The breast cancer drug could improve survival in patients in the more advanced stages of breast cancer.

Puma Biotechnology has announced that it will initiate the third phase of a clinical trial involving the potential breast cancer drug PB272 (neratinib).

The medicine could have applications in supporting those patients with the most advanced and difficult-to-treat varieties of disease, potentially allowing them a longer lifespan.

According to the US National Cancer Institute, the five-year survival rate for women with metastasised cancer was just 24.3 per cent between 2003 and 2009.

Researchers are planning to recruit 600 volunteers into the experiment, ensuring scientifically-demonstrable benefits by conducting a randomised controlled trial.

Investigators believe that the drug could increase survival rates in the cohort of patients, who are affected by third-line HER2-positive metastatic breast cancer.

Safe and verifiably-positive results will lead the biopharmaceutical company to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA).

Puma Biotechnology chief executive and president said: "We look forward to aggressively enrolling this trial and to pursuing additional registration opportunities for PB272."

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