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

NCT ID: NCT00080262

Last Updated: 2017-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Metastases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Ixabepilone

Intervention Type DRUG

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

Interventions

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Ixabepilone

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

Intervention Type DRUG

Other Intervention Names

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BMS-247550

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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R-Pharm

INDUSTRY

Sponsor Role lead

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

La Verne, California, United States

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Meriden, Connecticut, United States

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Jacksonville, Florida, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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New York, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Chattanooga, Tennessee, United States

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Jackson, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Buenos Aires, , Argentina

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Santa Fe, , Argentina

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Montreal, Quebec, Canada

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Besançon, , France

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Bobigny, , France

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Clermont-Ferrand, , France

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Dijon, , France

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Lyon, , France

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Marseille, , France

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Vandœuvre-lès-Nancy, , France

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Frankfurt, , Germany

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Frankfurt Hoechst, , Germany

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Mérida, Yucatán, Mexico

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Chihuahua City, , Mexico

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Distrito Federal, , Mexico

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Amsterdam, , Netherlands

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Leiden, , Netherlands

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Oslo, , Norway

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Trondheim, , Norway

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Port Elizabeth, Eastern Cape, South Africa

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Fichardtpark, Free State, South Africa

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Pretoria, Gauteng, South Africa

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Overport, KwaZulu-Natal, South Africa

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Panorama, Western Cape, South Africa

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Helsingborg, , Sweden

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Lund, , Sweden

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Malmo, , Sweden

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Stockholm, , Sweden

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Countries

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

References

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Perez EA, Lerzo G, Pivot X, Thomas E, Vahdat L, Bosserman L, Viens P, Cai C, Mullaney B, Peck R, Hortobagyi GN. Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2007 Aug 10;25(23):3407-14. doi: 10.1200/JCO.2006.09.3849. Epub 2007 Jul 2.

Reference Type BACKGROUND
PMID: 17606974 (View on PubMed)

Other Identifiers

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CA163-081

Identifier Type: -

Identifier Source: org_study_id

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