Clinical trial · Interventional
Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer
Phase II Randomized Trial of Weekly and Every 3-week Ixabepilone in Metastatic Breast Cancer (MBC) Patients
NCT00593827CI-TRIAL-00021305completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1
- description
- ixabepilone 16 mg/m\^2 weekly for 3 weeks followed by 1 week rest
- interventionNames
- Drug: Ixabepilone
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- ixabepilone 40 mg/m\^2 every 3 weeks
- interventionNames
- Drug: Ixabepilone
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months
- timeFrame
- From the date of randomization to 6-months on study
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.