Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Cyclophosphamide; Drug: Paclitaxel; Drug: Ixabepilone; Drug: Doxorubicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00455533

EUDRACT 2006-003047-24

CA163-100

Details and patient eligibility

About

The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomarkers as well as discover new biomarkers that could identify patients who are more likely to respond to ixabepilone than standard paclitaxel based therapy.

Enrollment: 384 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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384 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Doxorubicin

Drug: Ixabepilone

Drug: Cyclophosphamide

B

Active Comparator group

Treatment:

Drug: Doxorubicin

Drug: Paclitaxel

Drug: Cyclophosphamide