Weekly Paclitaxel Liposome Injection Plus Cisplatin in Pr... | NCT02142010

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

NCT02142010

Sponsor

Nanjing Luye Sike Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Aug 27, 2014Estimated

Enrollment

67Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

paclitaxel liposome injection plus cisplatin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Jun 2015Estimated

Completion Date

Not provided

First Submitted Date

May 9, 2014

First Submission Date that Met QC Criteria

May 19, 2014

First Posted Date

May 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2014

Last Update Posted Date

Aug 27, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
paclitaxel liposome injection plus cisplatin	Other		Drug: paclitaxel liposome injection plus cisplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
paclitaxel liposome injection plus cisplatin	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)

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

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds