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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Doxorubicin Hydrochloride Liposome injection and cyclophosphamide

pirarubicin and cyclophosphamide

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Fourth Hospital of Hebei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

Experimental group

Arm Description

Pirarubicin combination with cyclophosphamide,4 cycles (each cycle is 21days) of chemotherapy

Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide, 4 cycles (each cycle is 21 days) of chemotherapy

Outcomes

Primary Outcome Measures

pathological complete response

Secondary Outcome Measures

Full Information

NCT ID

NCT02903524

First Posted

September 13, 2016

Last Updated

September 15, 2016

Sponsor

Hebei Medical University Fourth Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02903524

Brief Title

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

Official Title

The Efficacy and Safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer ：a Randomised Multicentre, Open-label Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hebei Medical University Fourth Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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

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

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

Active Comparator

Arm Description

Pirarubicin combination with cyclophosphamide,4 cycles (each cycle is 21days) of chemotherapy

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide, 4 cycles (each cycle is 21 days) of chemotherapy

Intervention Type

Drug

Intervention Name(s)

Doxorubicin Hydrochloride Liposome injection and cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

pirarubicin and cyclophosphamide

Primary Outcome Measure Information:

Title

pathological complete response

Time Frame

until the completion of 4 cycles (each cycle is 21 days) of chemotherapy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Geng Cuizhi, archiater

Phone

0311-66696310

gengcuizhi@hotmail.com

Facility Information:

Facility Name

Fourth Hospital of Hebei Medical University

City

Shi Jiazhuang

State/Province

Hebei

ZIP/Postal Code

050019

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Geng Cuizhi, archiater

Phone

0311-66696310

gengcuizhi@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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