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

August 26, 2014 updated by: Nanjing Luye Sike Pharmaceutical Co., Ltd.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Jiaotong University School of Medicine, Renji Hospital
        • Contact:
        • Principal Investigator:
          • Jinsong Lu, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: paclitaxel liposome injection plus cisplatin
Drug: 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Luye Sike Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

May 9, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Estimate)

August 27, 2014

Last Update Submitted That Met QC Criteria

August 26, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY-TM-LPS-2014-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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