Clinical trial · Interventional
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Breast Cancer
Prospective, Multicenter, Randomized, Independent-group, Open-label Phase II Study to Investigate the Efficacy, Safety and Tolerability of 4 Regimen With 3 Doses of ZK 219477 (16 and 12 mg/m2 Body Surface Area as 3-hour Infusion or 22 mg/m2 Body Surface Area as 30-minute or 3-hour Infusion) in Patients With Metastatic Breast Cancer
NCT00288249CI-TRIAL-00016176completedPhase 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 determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer
Conditions
Conditions (2)
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 Cancer, Metastatic | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sagopilone (BAY86-5302, ZK 219477) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 \[30-minute infusion\] in Arm 3 and 22 mg/m2 \[3-hour infusion\] in Arm 4)
- interventionNames
- Drug: Sagopilone (BAY86-5302, ZK 219477)
- type
- EXPERIMENTAL
- label
- Arm 3
- description
- Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 \[30-minute infusion\] in Arm 3 and 22 mg/m2 \[3-hour infusion\] in Arm 4)
- interventionNames
- Drug: Sagopilone (BAY86-5302, ZK 219477)
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic breast cancer * No previous treatment with taxanes, and vinca alkaloids * Use of highly effective birth control methods in females of child-bearing potential Exclusion Criteria: * More than 2 previous chemotherapies * Previous participation in another trial within the last 4 weeks * Breast feeding * Active infections
References
Publications (0)
Data not yet available
No reference posted for this study.