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

September 15, 2016 updated by: Hebei Medical University Fourth Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Hebei
      • Shi Jiazhuang, Hebei, China, 050019
        • Recruiting
        • Fourth Hospital of Hebei Medical University
        • Contact:

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: control group
Pirarubicin combination with cyclophosphamide,4 cycles (each cycle is 21days) of chemotherapy
Drug: pirarubicin and cyclophosphamide
EXPERIMENTAL: Experimental group
Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide, 4 cycles (each cycle is 21 days) of chemotherapy
Drug: Doxorubicin Hydrochloride Liposome injection and cyclophosphamide

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Hebei Medical University Fourth Hospital

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

September 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (ESTIMATE)

September 16, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 16, 2016

Last Update Submitted That Met QC Criteria

September 15, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-DMS-BC-03

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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