Clinical trial · Interventional
A Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients With Taxane-Pretreated Recurrent Breast Cancer
A Clinical Trial of Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) in Patients With Taxane-Pretreated Recurrent Breast Cancer
NCT00912639CI-TRIAL-00002382unknownPhase 4ClinicalTrials.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 the response rate in patients with taxane-pretreated recurrent breast cancer receiving paclitaxel loaded polymeric micelle (Genexol-PM).
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 |
|---|---|---|---|
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel loaded Polymeric micelle | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Genexol-PM
- description
- All the patients are recurrent breast cancer after taxane treatment. Patients with a measurable lesion (at least 1 measurable lesion) 1. Spiral CT : lesion ≥ 10mm (unidimension) 2. X-ray, MRI, ultrasound : lesion ≥ 20 mm (unidimension)
- interventionNames
- Drug: Paclitaxel loaded Polymeric micelle
Primary outcomes (1)
- measure
- Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
- timeFrame
- 1 year
Secondary outcomes (3)
- measure
- Toxicity
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged \>=18 years 2. WHO (ECOG) performance status 0-2 3. Estimated life expectancy of \>=3 months 4. Have given written informed consent and are available for prolonged follow-up Exclusion Criteria: 1. Patients with previous chemotherapy for recurrent breast cancer 2. Breast cancer recurrence within 12 months after taxane treatment 3. Her-2/neu expression 4. Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin. 5. Brain metastasis 6. uncontrolled infection, medically uncontrollable heart disease 7. other serious medical illness or prior malignancies 8. Pregnant or lactating women were excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.