Doxorubicin Hydrochloride Liposome Injection Combination... | NCT02903524

Studies
Doxorubicin Hydrochloride Liposome Injection Combination With Cyclophosphamide vs Pirarubicin Combination With Cyclophosphamide in Patients With Locally Advanced Breast Cancer

NCT02903524

Sponsor

Hebei Medical University Fourth Hospital

Status

Unknown status

Last Update Posted

Sep 16, 2016Estimated

Enrollment

300Estimated

Phase

Phase 4

Conditions

Breast Cancer

Interventions

Doxorubicin Hydrochloride Liposome injection and cyclophosphamide
pirarubicin and cyclophosphamide

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

Status Module

Record Verification Date

Sep 2016

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

Sep 2016

Primary Completion Date

Sep 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Sep 13, 2016

First Submission Date that Met QC Criteria

Sep 15, 2016

First Posted Date

Sep 16, 2016Estimated

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

Sep 15, 2016

Last Update Posted Date

Sep 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

Evaluate the efficacy and safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer Patients

Detailed Description

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	Active Comparator	Pirarubicin combination with cyclophosphamide,4 cycles (each cycle is 21days) of chemotherapy	Drug: pirarubicin and cyclophosphamide
Experimental group	Experimental	Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide, 4 cycles (each cycle is 21 days) of chemotherapy	Drug: Doxorubicin Hydrochloride Liposome injection and cyclophosphamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doxorubicin Hydrochloride Liposome injection and cyclophosphamide	Drug		Experimental group
pirarubicin and cyclophosphamide

Measure	Description	Time Frame
pathological complete response		until the completion of 4 cycles (each cycle is 21 days) of chemotherapy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female patients with age between 18 and 70 years.
Newly diagnosed breast cancer, stages IIb-IIIc.
KPS performance status≥70.
Measurable disease according to RECIST version 1.1.
Normal cardiac function confirmed by baseline left ventricular ejection fraction (LVEF)≥50%.
Adequate bone marrow reserve (WBC≥4.0×10(9)/L, neutrophils≥2.0×10(9)/L, platelets≥100×10(9)/L,and hemoglobin≥90g/L).
Adequate hepatic and renal function.
AST and ALT ≤ 2×institutional upper limit of normal；alkaline phosphatase ≤ 2×institutional upper limit of normal；bilirubin ≤ institutional upper limit of normal.
Serum creatinine≥44 µmol/L and ≤133 µmol/L.
Written informed consent are acquired.
Not in pregnancy or the pregnancy tests of females is negative.

Exclusion Criteria:

Severe heart failure (NYHA grade II or higher).
Active and uncontrolled severe infection.
Have accepted any other anti-tumor drug within 30 days before the first dose or
received radiation treatment.
Other situations that investigators consider as contra-indication for this study.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Geng Cuizhi, archiater	Contact	0311-66696310		gengcuizhi@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fourth Hospital of Hebei Medical University	Recruiting	Shijiazhuang	Hebei	050019	China

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds