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news.Bristol-Myers Squibb says results from a Phase II study demonstrate that its investigational compound ixabepilone has activity in patients with metastatic breast cancer whose tumors were resistant to three types of standard chemotherapy.
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According to the company, there are currently few proven treatment options available to patients with breast cancer whose disease has rapidly progressed through or is not responding to prior treatment with approved chemotherapies.
The 126 patients enrolled in the single-arm Phase II study had heavily pretreated, advanced metastatic breast cancer, which had progressed through three prior therapies.
The primary endpoint was objective response rate, which is an assessment of the response to treatment as determined by the independent radiology facility (IRF). Secondary efficacy endpoints included duration of response, time to response, progression-free survival, and overall survival (OS), and with the exception of OS, analyses were based on IRF data.
The results showed that objective response rate was achieved in 11.5% of patients; a median duration of response of 5.7 months; a median time to response of 6.1 weeks; median progression-free survival of 3.1 months; and median overall survival of 8.6 months.
Ixabepilone is an investigational compound, a semisynthetic analog of epothilone B, designed to inhibit or prevent the growth or development of cancer cells.