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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
paclitaxel liposome injection plus cisplatin
Sponsored by
Nanjing Luye Sike Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Jiaotong University School of Medicine, Renji HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

paclitaxel liposome injection plus cisplatin

Arm Description

Outcomes

Primary Outcome Measures

pathological complete remission (pCR) rate

Secondary Outcome Measures

Adverse Events as a Measure of Safety and Tolerability
clinical response rate

Full Information

First Posted
May 9, 2014
Last Updated
August 26, 2014
Sponsor
Nanjing Luye Sike Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02142010
Brief Title
Weekly Paclitaxel Liposome Injection Plus Cisplatin in Preoperative Treatment of Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing Luye Sike Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
paclitaxel liposome injection plus cisplatin
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
paclitaxel liposome injection plus cisplatin
Intervention Description
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)
Primary Outcome Measure Information:
Title
pathological complete remission (pCR) rate
Time Frame
after 4 months of preoperative treatment
Secondary Outcome Measure Information:
Title
Adverse Events as a Measure of Safety and Tolerability
Time Frame
4 months during neoadjuvant therapy
Title
clinical response rate
Time Frame
after 4 months of preoperative therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinsong Lu, MD
Email
lujjss@126.com
Facility Information:
Facility Name
Shanghai Jiaotong University School of Medicine, Renji Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinsong Lu, MD
Email
lujjss@126.com
First Name & Middle Initial & Last Name & Degree
Jinsong Lu, Phd

12. IPD Sharing Statement

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

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