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CompletedNCT00020904Updated Jun 18, 2013

BMS-247550 in Treating Women With Metastatic Breast Cancer

A Phase 2 interventional study of ixabepilone in Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-18.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

OBJECTIVES:

  • 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • stage IV breast cancer
  • recurrent breast cancer
03

In context

Breast Neoplasms

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

Browse Breast Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

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

04

Who can participate

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

Eligibility criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Menopausal status:

  • Not specified

Sex:

  • Female

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 12 weeks

Hematopoietic:

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

Hepatic:

  • 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)

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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)

Radiotherapy:

  • 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

Surgery:

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

Other:

  • Recovered from all prior treatment-related toxic effects (alopecia allowed)
  • No other concurrent experimental anticancer medications
05

Study design

Phase
Phase 2
Primary purpose
Treatment

Interventions

  • Drugixabepilone
06

Study locations

2 sites
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10021, United States
  • Herbert Irving Comprehensive Cancer Center
    New York, New York 10032, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00020904
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
First posted
Sep 10, 2003
Start date
Feb 2001
Primary completion
Jan 2003
Completion
Jan 2003
Last update
Jun 18, 2013

Study contacts

Clifford A. Hudis, MD
study chair · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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