Conditions: Breast Cancer
Keywords: Breast Cancer Ixabepilone Ixempra Cyclophosphamide Cytoxan Neoadjuvant Therapy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 168
Healthy volunteers: no

Brief summary:
We propose to evaluate ixabepilone in combination with cyclophosphamide for the neoadjuvant treatment of locally advanced breast cancer. In this regimen, ixabepilone is substituted for docetaxel, since preclinical and clinical

studies suggest that ixabepilone is more active than either docetaxel or paclitaxel. The combination of ixabepilone and cyclophosphamide could further improve the efficacy of non-anthracycline neoadjuvant therapy.

Detailed description:
In this study, patients with early stage, HER2-negative breast cancer will receive neoadjuvant treatment with ixabepilone and cyclophosphamide given every three weeks for a total of six cycles. Following surgery patients with hormone receptor-positive tumors will receive anti-estrogen treatment. Patients may receive local regional radiation therapy after surgery per institutional guidelines at the investigator's discretion. Baseline tumor tissue and tumor tissue removed at the time of surgery will be tested by Oncotype Detailed Description (DX) assay to determine whether it is predictive of response to this neoadjuvant treatment regimen. This study will be one of the first investigations of the combination of ixabepilone and cyclophosphamide as neoadjuvant treatment for HER2-negative breast cancer. It will examine this treatment regimen for potential advantages gained from substitution of ixabepilone for a taxane and use of non-anthracycline agents.

Arms:
arm 1: Systemic Therapy followed by surgery and possible radiation therapy

Interventions: intervention 1: Ixabepilone intervention 2: Cyclophosphamide
Intervention descriptions: intervention 1: 40 mg/m2 IV infusion over 3 hours on day 1 of a 21 day cycle for 6 cycles intervention 2: 600 mg/m2 IV infusion per institutional guidelines on day 1 of a 21 day cycle for 6 cycles

Protocol document: