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Study 211 is a Phase II, open-label, single-arm study evaluating the efficacy and safety of Halaven® in patients with locally advanced or metastatic breast cancer who had received an anthracycline, a taxane and capecitabine as prior therapy, and who were refractory to their last chemotherapy regimen, as documented by progression on or within six months of that therapy. Of 299 patients enrolled in the study, 291 were treated with Halaven®. Two-hundred sixty-nine patients met the key inclusion criteria. Investigator-assessed ORR was 14.1% (1 CR). Nearly half (46.5%) the patients had stable disease after treatment with Halaven®. The clinical benefit rate was 17.1%. The median duration of response was 4.2 months. Median progression-free survival was 2.6 months, and the median overall survival rate was 10.3 months. The six-month PFS and OS rates were 16.0% and 72.3%, respectively.
The safety analysis included all 291 patients who received treatment with Halaven®. The most frequently reported Grade 3 or Grade 4 adverse events were neutropenia ,54%, febrile neutropenia, 5.5%, leukopenia,14%, and weakness/fatigue (10%; no Grade 4 events). Grade 3 peripheral neuropathy was reported in 5.5% of patients. No Grade 4 peripheral neuropathy events were reported.

EMBRACE was an open-label, randomized, global, multi-center, parallel two-arm study designed to compare overall survival in patients treated with Halaven® versus a Treatment of Physician’s Choice (TPC). The study included 762 patients with locally recurrent or metastatic breast cancer who previously had been treated with at least two and a maximum of five prior chemotherapies, including an anthracycline and a taxane. Patients were randomized at a ratio of two-to-one to receive either Halaven® or TPC. TPC was defined as any single-agent chemotherapy, hormonal treatment or biologic therapy approved for the treatment of cancer; or palliative treatment or radiotherapy administered according to local practice. The vast majority (97 percent) of patients in the TPC arm received chemotherapy.

The most common adverse reactions (incidence greater than or equal to 25 percent) among patients treated with Halaven® were asthenia (fatigue), neutropenia, anemia, alopecia (hair loss), peripheral neuropathy (numbness and tingling in arms, legs and other parts of the body), nausea and constipation. The most common serious side effects reported in patients receiving Halaven® were neutropenia with or without fever (4 percent and 2 percent, respectively). The most common adverse reaction resulting in discontinuation of treatment with Halaven® was peripheral neuropathy (5 percent).

In Switzerland, 5,918 were diagnosed as the breast cancer and 1,367 have died in 2008.