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news.Eisai has started a large, randomized Phase III trial to compare the efficacy, safety and tolerability of eribulin mesylate injection to standard weekly paclitaxel as a first or second- line treatment for HER2-negative locally recurrent or metastatic breast cancer (MBC).
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Recruitment is currently in process for the multicenter trial, which is being conducted in partnership with the Academic and Community Cancer Research United (ACCRU) group.
Across the US, about 910 patients are expected to be enrolled in the trial, which involves an investigational use of eribulin mesylate.
The trial is intended for patients with HER2-negative breast cancer who have received no more than one prior chemotherapy regimen once their breast cancer has spread.
The company said that eligible patients will be randomly selected with equal allocation (1:1) to receive treatment for their cancer with either eribulin mesylate or standard weekly paclitaxel, within strata defined by prior adjuvant taxanes, hormone receptor status (ER/PgR), and line of therapy.
Primary endpoint of the trial is overall survival, while secondary endpoints include progression-free survival and objective tumor response rate.
In the trial, safety and tolerability of the treatment groups will also be continuously monitored.
MBC is the form of the disease that refers to the most advanced stage in which cancer cells break away from the tumor in the breast, spread to other parts of the body and continue growing.