CClinicalTrials.gg
CompletedNCT00080262Updated Jan 30, 2017

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

A Phase 2 interventional study of Ixabepilone in Breast Cancer and Metastases, sponsored by R-Pharm. Completed at 45 sites in 10 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-30.

Sponsored by R-Pharm · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
125
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Breast Cancer
  • Metastases

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Keywords

  • Metastatic Breast Cancer
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 125 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

R-Pharm is the lead sponsor of 55 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
125 participants

Study arms

  • Experimental
    1

    Drug: Ixabepilone

Interventions

  • DrugIxabepilone

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

    Also known as: BMS-247550

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What researchers measure

Primary outcomes

  1. Response rate as determined by the IRRC

Secondary outcomes

  1. Time to progression, duration of response, overall survival

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Study locations

45 sites
  • 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
  • Local Institution
    Chattanooga, Tennessee, United States
  • Local Institution
    Jackson, Tennessee, United States
  • Local Institution
    Knoxville, Tennessee, United States
  • Local Institution
    Nashville, Tennessee, United States
  • Local Institution
    Houston, Texas, United States
  • Local Institution
    San Antonio, Texas, United States
  • Local Institution
    Salt Lake City, Utah, United States
  • Local Institution
    Buenos Aires, Argentina
  • Local Institution
    Santa Fe, Argentina
  • Local Institution
    Montreal, Quebec, Canada
  • Local Institution
    Besancon Cedex, France
  • Local Institution
    Bobigny, France
  • Local Institution
    Clermont-Ferrand, France
  • Local Institution
    Dijon Cedex, France
  • Local Institution
    Lyon, France
  • Local Institution
    Marseille Cedex 9, France
  • Local Institution
    Vandoeuvre Les Nancy, France
  • Local Institution
    Frankfurt Hoechst, Germany
  • Local Institution
    Frankfurt, Germany
  • Local Institution
    Merida, Yucatan, Mexico
  • Local Institution
    Chihuahua, Mexico
  • Local Institution
    Distrito Federal, Mexico
  • Local Institution
    Amsterdam, Netherlands
  • Local Institution
    Leiden, Netherlands
  • Local Institution
    Oslo, Norway
  • Local Institution
    Trondheim, Norway
  • Local Institution
    Port Elizabeth, Eastern Cape, South Africa
  • Local Institution
    Fichardtpark, Free State, South Africa
  • Local Institution
    Pretoria, Gauteng, South Africa
  • Local Institution
    Overport, Kwa Zulu Natal, South Africa
  • Local Institution
    Panorama, Western Cape, South Africa
  • Local Institution
    Helsingborg, Sweden
  • Local Institution
    Lund, Sweden
  • Local Institution
    Malmo, Sweden
  • Local Institution
    Stockholm, Sweden
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References and documents

Publications

  • 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. PubMed 17606974 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00080262
Lead sponsor
R-Pharm
First posted
Mar 26, 2004
Start date
Feb 2004
Primary completion
Dec 2006
Completion
Dec 2006
Last update
Jan 30, 2017

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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