Clinical trial · Interventional
Weekly Paclitaxel Liposome Injection Plus Cisplatin in Preoperative Treatment of Breast Cancer
NCT02142010CI-TRIAL-00015480unknownN/AClinicalTrials.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 pathological complete response (pCR) rate in breast cancer patients treated with weekly paclitaxel liposome injection plus cisplatin preoperative regimen.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel liposome injection plus cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- paclitaxel liposome injection plus cisplatin
- interventionNames
- Drug: paclitaxel liposome injection plus cisplatin
Primary outcomes (1)
- measure
- pathological complete remission (pCR) rate
- timeFrame
- after 4 months of preoperative treatment
Secondary outcomes (2)
- measure
- Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- 4 months during neoadjuvant therapy
- measure
- clinical response rate
- timeFrame
- after 4 months of preoperative therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged ≥ 18 years and \< 65 years,An estimated life expectancy of at least 12 months * ECOG 0-1 * At least one measurable disease according to the RECIST. histologically confirmed invasive breast cancer, stage II and III, no prior systemic or loco-regional treatment of breast cancer * Biopsy specimens are available for ER, PgR and Her2 analysis * Adequate bone marrow function: Neutrophil ≥ 1.5\*109/L; Hb ≥ 100g/L; PLT ≥ 100\*109/L * adequate liver function (bilirubin \> 1.0 times upper normal limit \[UNL\] and ALT and/or AST\> 1.5 UNL associated with alkaline phosphatase \> 2.5 UNL; * Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study * No obvious main organs dysfunction * patients must be accessible for treatment and follow-up and written informed consent Exclusion Criteria: * Patient is pregnant or breast feeding * Inflammatory breast cancer and Metastatic breast cancer * Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease * History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP \> 180 mmHg or diastolic BP \> 100 mmHg) * Has peripheral neuropathy * Treatment with any investigational drugs within 30 days before the beginning of study treatment * No psychiatric illness and other situations that would limit compliance of study * With a history of other malignant tumor * Known severe hypersensitivity to any drugs in this study
References
Publications (0)
Data not yet available
No reference posted for this study.