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

NCT ID: NCT02142010

Last Updated: 2014-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

paclitaxel liposome injection plus cisplatin

Group Type: OTHER

paclitaxel liposome injection plus cisplatin

Intervention Type: DRUG

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)

Interventions

paclitaxel liposome injection plus cisplatin

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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Luye Sike Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jinsong Lu, MD

Role: CONTACT

lujjss@126.com

Facility Contacts

Jinsong Lu, MD

Role: primary

lujjss@126.com

Other Identifiers

LY-TM-LPS-2014-01

Identifier Type: -

Identifier Source: org_study_id