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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Metastases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ixabepilone

Drug

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

Other names: BMS-247550

Primary outcomes

Response rate as determined by the IRRC

Secondary outcomes

Time to progression, duration of response, overall survival

Sponsors and collaborators

Lead sponsor

R-Pharm

Industry

Registry information

Official study title

Phase II Study of Novel Epothilone (BMS-247550) in Patients With MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Mar 26, 2004
Registry last updated: Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed