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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00080262

Enrollment

125

Registered

2004-03-26

Start date

2004-02-29

Completion date

2006-12-31

Last updated

2017-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Metastases

Keywords

Metastatic Breast Cancer

Brief summary

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.

Interventions

DRUGIxabepilone

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response rate as determined by the IRRC	—

Secondary

Measure	Time frame
Time to progression, duration of response, overall survival	—

Countries

Argentina, Canada, France, Germany, Mexico, Netherlands, Norway, South Africa, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026