Phase 2
Completed N=176
Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00593827 ↗Enrolled (actual)
176
Serious AEs
32.2%
Results posted
May 2012
Primary outcomePrimary: Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months — 28.6; 42.7 Percentage of Participants — p=0.03
Summary
The purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months |
28.6; 42.7 | 0.03 sig |
| SECONDARY Median Progression Free Survival |
2.9; 5.3 | 0.05 |
| SECONDARY Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST] |
7.6; 13.5 | — |
| SECONDARY Best Response as Assessed With RECIST |
0; 1.1; 7.6; 12.4; 40.5; 44.9 | — |
| SECONDARY Overall Survival (OS) |
13.9; 16.1 | 0.11 |
| SECONDARY Time to Response |
2.5; 2.8 | — |
| SECONDARY Duration of Response |
6.2; 6.3 | — |
| SECONDARY Incidence of All Grades of Peripheral Neuropathy |
26; 39; 9; 15; 10; 10 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00593827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.