Clinical trial · Interventional
Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer
Phase 2 Study to Investigate the Efficacy and Safety of ZK-Epothilone (ZK-Epo; ZK 219477) in Patients With Metastatic Breast Cancer
NCT00313248CI-TRIAL-00020151completedPhase 2ClinicalTrials.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 is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop tumor growth.
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 |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sagopilone (ZK 219477) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: Sagopilone (ZK 219477)
- type
- EXPERIMENTAL
- label
- Arm 2
- interventionNames
- Drug: Sagopilone (ZK 219477)
Primary outcomes (1)
- measure
- Response to treatment with ZK-Epo after 6 cycles
- timeFrame
- complete or partial response after 2 to 6 courses of therapy.
Secondary outcomes (1)
- measure
- Safety and tolerability of ZK-Epo
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic breast cancer (meaning the cancer has spread beyond its original location) * At least one measurable lesion by CT or MRI * Progression of disease following previous therapy for breast cancer * Have received previous treatment with anthracyclines (e.g. doxorubicin\[Adriamycin or Doxil\] or epirubicin \[Ellence\]), taxanes (paclitaxel \[Taxol or Abraxane\] or docetaxel \[taxotere\]) for your breast cancer * Not be pregnant * Additional criteria to be determined at screening visit. Exclusion Criteria: * More than 3 previous chemotherapy regimens * More than one treatment with non cytotoxic agents for breast cancer therapy (e.g. herceptin \[trastuzumab\] or Avastin \[bevacizumab) * Prior treatment with epothilones (e.g. Ixabepilone) * Symptomatic brain metastases * Additional criteria to be determined at screening visit
References
Publications (1)
- DERIVEDMorrow PK, Divers S, Provencher L, Luoh SW, Petrella TM, Giurescu M, Schmelter T, Wang Y, Hortobagyi GN, Vahdat LT. Phase II study evaluating the efficacy and safety of sagopilone (ZK-EPO) in patients with metastatic breast cancer that has progressed following chemotherapy. Breast Cancer Res Treat. 2010 Oct;123(3):837-42. doi: 10.1007/s10549-010-1102-x. Epub 2010 Aug 10. PMID 20697802