BMS-247550 in Treating Women With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00020904
Recruitment Status : Completed
First Posted : September 10, 2003
Last Update Posted : June 18, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating women who have stage IV or recurrent metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: ixabepilone Phase 2

Detailed Description:


  • Determine the clinical activity of BMS-247550, in terms of tumor response rate, in women with taxane-resistant metastatic breast cancer.
  • Determine the safety of this drug in these patients.
  • Determine the duration of response, time to progression, and survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive BMS-247550 IV over 3 hours on day 1. Treatment continues every 3 weeks for 4-18 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 4 additional courses beyond CR. Responding patients may receive additional courses at the investigator's discretion.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 14-50 patients will be accrued for this study within 12 months.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study of Epothilone B Analog BMS-247550 in Patients With Taxane-Resistant Metastatic Breast Cancer
Study Start Date : February 2001
Actual Primary Completion Date : January 2003
Actual Study Completion Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Ixabepilone

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed metastatic breast carcinoma

    • Stage IV or recurrent disease with distant metastases
  • Most recent prior chemotherapy was docetaxel-based or paclitaxel-based therapy for metastatic disease

    • Progressed during therapy or within 4 months of last dose OR
    • Progressed during therapy or within 6 months of last dose if given as adjuvant treatment only
  • Received prior anthracycline therapy
  • Bidimensionally measurable metastatic lesion

    • Bony lesions not considered measurable
  • No known brain metastases
  • Hormone receptor status:

    • Not specified



  • 18 and over

Menopausal status:

  • Not specified


  • Female

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 12 weeks


  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count greater than 125,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases are present)


  • Creatinine no greater than 1.5 times ULN


  • No unstable angina, myocardial infarction, or congestive heart failure within the past 6 months


  • No grade 2 or greater neuropathy (motor or sensory)
  • No uncontrolled infection or other medical illness that would preclude study
  • No psychiatric disorder or other condition that would preclude study
  • No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No hypersensitivity to agents containing Cremophor EL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 24 hours since prior growth factor
  • No concurrent trastuzumab (Herceptin)
  • No concurrent immunotherapy


  • See Disease Characteristics
  • No more than 1 prior chemotherapy regimen for metastatic disease except an anthracycline-containing regimen as first-line therapy and a taxane as second-line therapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy (except hormone replacement therapy)


  • At least 3 weeks since prior radiotherapy, except palliative radiotherapy to less than 20% of the bone marrow, and recovered
  • No prior radiotherapy to major bone marrow-containing areas (pelvis and lumbar spine)
  • No prior radiotherapy to target lesion if only measurable lesion
  • No concurrent therapeutic radiotherapy


  • At least 1 week since prior minor surgery
  • At least 3 weeks since prior major surgery
  • Recovered from prior surgery


  • Recovered from all prior treatment-related toxic effects (alopecia allowed)
  • No other concurrent experimental anticancer medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00020904

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Clifford A. Hudis, MD Memorial Sloan Kettering Cancer Center Identifier: NCT00020904     History of Changes
Other Study ID Numbers: 01-031
CDR0000068729 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 10, 2003    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases