This case study outlines an open-label, randomised, multi-centre study to evaluate the use of a study drug in the prevention of cancer treatment-related bone loss in post-menopausal women with estrogen-receptor-positive (ER+) and/or progesterone receptor positive (PR+) breast cancer receiving letrozole as adjuvant therapy.

A long-standing top 20 pharmaceutical client awarded PRA a Phase IIIb study involving the treatment of cancer-related bone loss in post-menopausal women with breast cancer. The study was to be conducted in 600 patients at 115 sites in Canada and the US.

Although the sites were activated on schedule, patient recruitment fell behind by five weeks. PRA and the client worked together to interview the investigational sites to identify the causes of delay.