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

CompletadoFase 2ClinicalTrials.gov

ID: NCT00455533Tipo: INTERVENTIONALInicio: 1 de oct de 2007Fin estimado: 1 de dic de 2009

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Ixabepilone

Intravenous Solution, intravenous (IV), 40mg/m², Day 1 every 21 days, 12 Weeks

drug

Paclitaxel

Intravenous Solution, IV, 80mg/m², Weekly, 12 Weeks

drug

Cyclophosphamide

Intravenous Solution, IV, 600mg/m², Day 1 every 21 days, 12 Weeks

drug

Doxorubicin

Intravenous Solution, IV, 60mg/m², Day 1 every 21 days, 12 Weeks

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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