Phase 3 study of Myocet for metastatic breast cancer

Sopherion Therapeutics announced that enrollment is completed in its pivotal Phase 3 study of Myocet (nonpegylated liposomal doxorubicin) in metastatic HER-2-overexpressing breast cancer. This is a randomized, multicenter study evaluating Myocet in combination with the current standard of care, Taxol (paclitaxel) and Herceptin (trastuzumab), versus paclitaxel and trastuzumab alone. Eligibility criteria included no prior chemotherapy for metastatic disease, nor any trastuzumab, anthracyclines or taxanes within the previous 12 months. Progression-free survival (PFS) is the primary efficacy endpoint, with careful monitoring for cardiac safety.

Myocet is a liposome-encapsulated doxorubicin-citrate complex designed to reduce doxorubicin’s toxicity.

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