Study 081:
A single-arm, Phase II trial of IXEMPRA (ixabepilone) monotherapy in 126 metastatic breast cancer patients pretreated with, and resistant to, an anthracycline,* a taxane, and capecitabine.1,2
Objective tumor response rate was the primary end point and was evaluated by independent radiologic and investigator review using Response Evaluation Criteria in Solid Tumors (RECIST)
Resistance to anthracyclines and taxanes was defined as1,2:
- Disease progression while on treatment, or within 8 weeks of the last dose, in the metastatic setting
- Recurrence within 6 months of the last dose in the adjuvant or neoadjuvant setting (for anthracyclines
and taxanes)
- Progression during or after discontinuation of trastuzumab for patients who were HER2+
Patients received IXEMPRA 40 mg/m² IV over 3 hours every 3 weeks1
*For anthracyclines, patients who received a minimum cumulative dose of 240 mg/m² of doxorubicin or 360 mg/m² of epirubicin were also eligible.
Safety Information: Hepatic Impairment
- Assessment of hepatic function is recommended before initiation of IXEMPRA and periodically thereafter
- Patients with baseline AST or ALT >2.5 × ULN or bilirubin >1.5 × ULN experienced greater toxicity than patients with
baseline AST or ALT ≤2.5 × ULN or bilirubin ≤1.5 × ULN when treated with IXEMPRA at 40 mg/m2 as monotherapy in
breast cancer studies
- With monotherapy, grade 4 neutropenia, febrile neutropenia, and serious adverse reactions were more frequent
AST = aspartate aminotransferase; ALT = alanine aminotransferase; ULN = upper limit of normal.
Please see complete Important Safety Information, including Boxed WARNING regarding hepatic impairment.
Efficacy