Clinical trial · Interventional
Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
A Multicenter Phase 3, Randomized Comparison of the Safety and Efficacy of Weekly TOCOSOL(R) Paclitaxel vs. Weekly Paclitaxel Injection in the Treatment of Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Failed primary endpoint
Summary
Brief summary (as posted)
The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patients with metastatic breast cancer. The study hypothesis is that the objective response rate with TOCOSOL Paclitaxel given every week is non-inferior to that observed with Taxol given every week.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Taxol | Drug | Taxol | ALIAS |
| TOCOSOL Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Taxol
- description
- Taxol 80mg/m2/week
- interventionNames
- Drug: Taxol
- type
- EXPERIMENTAL
- label
- TOCOSOL
- description
- TOCOSOL Paclitaxel
- interventionNames
- Drug: TOCOSOL Paclitaxel
Primary outcomes (2)
- measure
- Objective response rates
- timeFrame
- Based on enrollment
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologic diagnosis of breast carcinoma * Stage IV (M1) disease * Adult (18 years of age or older) patients Exclusion Criteria: * Patients treated with a taxane within the past year * Patients whose tumor tissue is known to show over expression of HER2/neu
References
Publications (0)
Data not yet available