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

Not Applicable

• Conditions: Breast Cancer
• Interventions: Drug: paclitaxel liposome injection plus cisplatin

• Registration Number: NCT02142010
• Lead Sponsor: Nanjing Luye Sike Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-09
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-20
• Status Verified: 2014-08
• Study Start: 2014-08
• Last Update Submitted: 2014-08-26
• Last Update Posted: 2014-08-27
• Primary Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
paclitaxel liposome injection plus cisplatin	paclitaxel liposome injection plus cisplatin	-

Primary Outcome Measures

Name	Time	Method
pathological complete remission (pCR) rate	after 4 months of preoperative treatment

Secondary Outcome Measures

Name	Time	Method
clinical response rate	after 4 months of preoperative therapy
Adverse Events as a Measure of Safety and Tolerability	4 months during neoadjuvant therapy

Trial Locations

Locations (1)

Shanghai Jiaotong University School of Medicine, Renji Hospital; 🇨🇳 Shanghai, China