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Phase II Randomized Trial of Weekly and Every 3-week Ixabepilone in Metastatic Breast Cancer (MBC) Patients

Phase 2
18 Years
Not Enrolling
Metastatic Breast Cancer

Thank you

Trial Information

Phase II Randomized Trial of Weekly and Every 3-week Ixabepilone in Metastatic Breast Cancer (MBC) Patients

Inclusion Criteria:

- Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29
(or CA15.3) ≥ 50

- Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer

- Prior chemotherapy is permitted with no limit on the number of prior regimens

- Two weeks or more have elapsed since last chemotherapy or radiation treatment

- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2

- Is female, ≥ 18 yrs of age

- Protocol defined appropriate laboratory values

- Negative pregnancy test within 7 calendar days prior to registration

- Has signed a patient informed consent

Exclusion Criteria:

- Had prior treatment with ixabepilone or other epothilones

- Has HER2+ disease

- Has a known, prior, severe (National Cancer Institute Common Terminology Criteria
Adverse Events [NCI CTCAE] Grade 3-4) history of hypersensitivity reaction to a drug
formulated in Cremophor ® EL (polyoxyethylated castor oil)

- Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy

- Is receiving concurrent investigational therapy or has received such therapy within
the past 30 days

- Has peripheral neuropathy > Grade 1

- Has evidence of central nervous system (CNS) involvement requiring radiation or
steroid treatment. Participants with stable brain metastases who are off steroids at
least 2 weeks are eligible

- Is pregnant or breast feeding

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months

Outcome Description:

PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.

Outcome Time Frame:

From the date of randomization to 6-months on study

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

August 2010

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms



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