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



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2007
End Date:December 2009

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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

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.


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
We found this trial at
11
sites
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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Bronx, New York 10461
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Capital Federal, Buenos Aires
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Coral Spring, Florida 33065
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Davie, Florida 33328
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Lake Worth, Florida 33467
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Louisville, Kentucky 40202
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Palm Springs, California 92262
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Spokane, Washington 99204
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Spokane, WA
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Tampa, Florida 33612
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Tampa, FL
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