Clinical trial · Interventional
Phase I Combination w/ Epirubicin
A Phase I Study of Ixabepilone in Combination With Epirubicin in Patients With Metastatic Breast Cancer
NCT00322374CI-TRIAL-00021301completedPhase 1Results 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)
Tumor response information was obtained for all participants who received at least 2 cycles of study drug, underwent requisite baseline and on-treatment disease assessments and had at least one post-treatment assessment. Tumor response assessment in evaluable participants was done according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epirubicin | Drug | Epirubicin | ALIAS |
| Ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 25 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin
- description
- Participants received 25 mg/m\^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m\^2 epirubicin every 21 days.
- interventionNames
- Drug: Ixabepilone
- Drug: Epirubicin
- type
- EXPERIMENTAL
- label
- 30 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin
- description
- Participants received 30 mg/m\^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m\^2 epirubicin every 21 days.
- interventionNames
- Drug: Ixabepilone
- Drug: Epirubicin
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women ≥18 years * Histologically or cytologically confirmed diagnosis of metastatic breast cancer * Measurable or nonmeasurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST) Exclusion Criteria: * Number of prior chemotherapy lines of treatment in the metastatic setting ≥2
References
Publications (0)
Data not yet available
No reference posted for this study.