Novel Epothilone (BMS-247550) in Patients With Metastatic Breast Cancer (MBC)

R-Pharm125 enrolled

Overview

The purpose of this research study is to assess the response rate of the investigational drug BMS-247550 (Ixabepilone) in women with metastatic breast cancer who are refractory to an anthracycline, a taxane, and capecitabine.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

125

Conditions

Breast Cancer Metastases

Interventions

IxabepiloneDRUG

Solution, IV, 40 mg/m2, every 21 days, extended, until PD or discontinued for other reasons.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must have received all 3 drugs- an anthracycline, taxane, and capecitabine (alone or in combination) and be resistant * No more than 3 prior chemotherapy regimens in the metastatic setting * Must have at least one target lesion that is radiographically measurable * Good performance status * No history of or current brain or leptomeningeal disease

Locations (45)

Outcomes

Primary Outcomes

Response rate as determined by the IRRC

Secondary Outcomes

Time to progression, duration of response, overall survival

Data from ClinicalTrials.gov

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Local Institution

La Verne, California, United States

Local Institution

Meriden, Connecticut, United States

Local Institution

Jacksonville, Florida, United States

Local Institution

Baltimore, Maryland, United States

Local Institution

Boston, Massachusetts, United States

Local Institution

New York, New York, United States

Local Institution

Asheville, North Carolina, United States

Local Institution

Charlotte, North Carolina, United States

Local Institution

Pittsburgh, Pennsylvania, United States

Local Institution

Providence, Rhode Island, United States

...and 35 more locations