Clinical trial · Interventional
Comparison of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer
A Phase II Randomized Clinical Trial of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer
NCT00919880CI-TRIAL-00015389completedPhase 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 neo-adjuvant weekly paclitaxel with carboplatin is better than paclitaxel alone in efficiency and safety in early breast cancer, and to explore whether ultrasound and magnetic resonance imaging can predict the efficiency of neo-adjuvant chemotherapy.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin+ paclitaxel | Drug | Carboplatin/Paclitaxel Regimen | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental
- interventionNames
- Drug: carboplatin+ paclitaxel
- Drug: paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator
- interventionNames
- Drug: paclitaxel
Primary outcomes (1)
- measure
- significant effect rate (the proportion of G4 and G5, graded by Miller & Payne Method); null effect rate (the proportion of G1 and G2)
- timeFrame
- within the first 14 days (plus or minus 3 days) after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * female patients between 18 and 65 years old * pathological diagnosed invasive breast cancer; medium and high risk primary breast cancer according to St. Gallen 2007 * able and willing to give consent to participate in the study Exclusion Criteria: * pregnant or lactating females * previous treatment for breast cancer * other tumor history * instable complication (e.g., myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or uncontrolled infection * allergy history to similar drugs * concurrent disease or condition that would make the patient inappropriate for study participation * resist to participate in the study
References
Publications (0)
Data not yet available
No reference posted for this study.