Merck KGaA has initiated a global Phase III clinical study of Stimuvax, an investigational vaccine to treat patients with advanced, inoperable breast cancer.

Stimuvax (BLP25 liposome vaccine, L-BLP25) is an investigational therapeutic cancer vaccine designed to stimulate the body’s immune system to identify and target cancer cells that express MUC1, an antigen commonly expressed in breast cancer as well as in other common cancer types.

The study (STRIDE) will determine if Stimuvax can extend progression-free survival in patients treated with hormonal therapy who have hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer.

In addition, overall survival, quality of life, tumour response and safety will be assessed in the study.

Dana-Farber Cancer Institute CMO and senior vice-president for medical affairs Lawrence Shulman said new treatment options for advanced-stage breast cancer are urgently needed, as it remains a devastating and challenging disease.

“If the results from the Phase III STRIDE study prove positive, this could make a difference for patients with hormone receptor positive metastatic breast cancer,” Shulman said.

More than 900 patients with advanced breast cancer will be enrolled in the STRIDE study at an estimated 180 sites in over 30 countries.