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Clinical Trial Testing New, Current Breast Cancer Drugs

Breast self-exam

(National Cancer Institute)

27 February 2014. The global pharmaceutical company Eisai Inc. is starting a late-stage clinical trial of its drug eribulin mesylate to treat certain types of recurring or metastatic breast cancer, compared to the current chemotherapy drug paclitaxel. The trial is a joint project of Eisai’s U.S. subsidiary, in Woodcliff Lakes, New Jersey, and Academic and Community Cancer Research United, a clinical research network based at the Mayo Clinic in Rochester, Minnesota. Eisai’s headquarters is in Tokyo.

The study aims to enroll 910 patients with HER2-negative locally recurrent or metastatic (spreading) breast cancer, having no more than one previous course of chemotherapy. Human epidermal growth factor receptor 2 or HER2 genes generate proteins that regulate breast growth. The over-expression of those proteins contributes to uncontrolled growth of breast cells and accounts for about a quarter of breast cancer cases. HER2-negative status indicates HER2 genes are not over-expressing and thus not contributing to the cancer’s spread.

The trial tests eribulin mesylate, marketed by Eisai as Halaven, against the standard chemotherapy drug paclitaxel, as an initial cancer treatment or as a back-up treatment if the first-line treatment does not work or stops working. The primary effectiveness measure in the trial is overall survival of the patients, while the study will also follow progression-free survival and objective tumor response rate, as well as safety and tolerability of the drugs.

Patients in the trial will be randomly divided between receiving eribulin mesylate or paclitaxel, with both drugs administered as intravenous injections. Eribulin mesylate is given once a week over a three-week period, while paclitaxel is also administered once a week, but over four weeks. Paclitaxel is marketed as Abraxane by Celgene Corp., and also available in generic forms.

Eribulin mesylate is a synthetic form of the natural compound halichondrin B, derived from the Halichondria okadai sea sponge. While early lab tests showed the compound’s potential as cancer treatment, extracting sufficient quantities in its natural state proved to be difficult. Research at Harvard University in the 1990s showed it was possible to synthesize the halichondrin B, and Eisai licensed the process which eventually led to development of its Halaven product.

Academic and Community Cancer Research United is recruiting patients for the trial. Only one location — Rochester, New York — is so far identified.

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