Weekly Paclitaxel Liposome Injection Plus Cisplatin in Preoperative Treatment of Breast Cancer

Study Overview
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Brief Summary
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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
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Breast Cancer

Intervention / Treatment
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* Drug: paclitaxel liposome injection plus cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: paclitaxel liposome injection plus cisplatin<br> | Drug: paclitaxel liposome injection plus cisplatin<br>* Paclitaxel liposome injection 80 mg/m2, given on days 1, 8,15 and 22 of a 28-day cycle. Cisplatin 25 mg/m2, given on days 1, 8 and 15 of a 28-day cycle, for 4 cycles(4 months)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological complete remission (pCR) rate |  | after 4 months of preoperative treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events as a Measure of Safety and Tolerability |  | 4 months during neoadjuvant therapy | 
| clinical response rate |  | after 4 months of preoperative therapy |