A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women With Early Stage Breast Cancer

Inclusion Criteria

Inclusion criteria

- Histologically confirmed primary invasive adenocarcinoma of the breast , T2-3, N0-3,
M0, with tumor size of ≥ 2 cm

- All patients with early stage breast adenocarcinoma may enroll irrespective of
receptor status

- No prior treatment for breast cancer excluding therapy for DCIS

- Karnofsky performance status of 80 - 100

- left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or multiple gated
acquisition (MUGA)

- Adequate hematologic, hepatic and renal function

Exclusion Criteria

- women of child-bearing potential (WOCBP) unwilling or unable to use an acceptable
method to avoid pregnancy during and up to 8 weeks after the last dose of the
investigational drug

- Women who are pregnant or breastfeeding

- Inflammatory or metastatic breast cancer

- Unfit for breast and/or axillary surgery

- Evidence of baseline sensory or motor neuropathy

- Significant history of cardiovascular disease, serious intercurrent illness or
infections including known human immu immunodeficiency virus (HIV) infection

- History of prior anthracycline therapy Allergies to any study medication or
Cremophor® EL