Spots Global Cancer Trial Database for Ixabepilone in Treating Patients With Locally Advanced or Metastatic Breast Cancer

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Trial Identification

Brief Title: Ixabepilone in Treating Patients With Locally Advanced or Metastatic Breast Cancer

Official Title: A Phase II Clinical Trial Of BMS-247550 (NSC 710428), An Epothilone B Analog, In Patients With Breast Carcinoma

Study ID: NCT00045097

Conditions

Breast Cancer

Interventions

ixabepilone

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with locally advanced or metastatic breast cancer.

Detailed Description: OBJECTIVES: * Determine any antitumor activity of ixabepilone, in terms of objective response rate, in patients with incurable, locally advanced or metastatic breast cancer. * Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to prior taxane therapy (yes vs no). Patients (with or without prior taxane exposure) receive ixabepilone IV over 1 hour on days 1-5. An additional cohort of 37 patients who have received prior taxane therapy are then accrued to receive ixabepilone IV over 1 hour on days 1-3 at a higher starting dose. For all patients, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who receive more than 6 courses with satisfactory response may be treated every 4-5 weeks. Patients removed for unacceptable toxicty are followed periodically. PROJECTED ACCRUAL: A total of 105 patients (at least 74 with and 21 without prior taxane exposure) will be accrued for this study within 26 months.