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. 2008 Sep;33(9):523–531.

Table 1.

Response Rates in Clinical Trials of Ixabepilone Monotherapy in Metastatic Breast Cancer: Key Phase 2 Trials

Trial Eligibility Criteria No. Dose and Schedule Response Rate
Baselga et al.41 Neoadjuvant therapy in patients with locally advanced breast cancer 164 40 mg/m2 q3w pCR rate, 19%
Denduluri et al.40 1st- or >2nd-line therapy in patients with taxanenaive MBC 23 6 mg/m2 days 1–5 q3w ORR, 57%; SD rate, 26%
Roché et al.39 1st-line therapy in patients with MBC previously treated with an adjuvant anthracycline 65 40 mg/m2 q3w ORR, 41.5%; SD rate, 35%
Low et al.38 1st- 2nd-, or >3rd-line therapy in patients previously treated with a taxane as prior neoadjuvant, adjuvant, or metastatic therapy 37 6 mg/m2 days 1–5 q3w ORR, 22%; SD rate, 35%
Thomas et al.37 1st-, 2nd-, 3rd-, or 4th-line therapy in patients with taxane-resistant MBC 49 40 mg/m2 q3w ORR, 12%; SD rate, 41%
Perez et al.36 3rd- or 4th-line therapy in patients with MBC resistant to anthracyclines, taxanes, and capecitabine 126 40 mg/m2 q3w ORR, 11.5%; SD rate, 50%
Denduluri et al.42 Patients with MBC who have received prior taxane therapy 12 8–10 mg/m2 q3w ORR, 0%; SD rate for ≥6 weeks, 83%

MBC = metastatic breast cancer; ORR = objective response rate; q3w = every 3 weeks; pCR = pathological complete response; SD = stable disease.