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

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ClinicalTrials.gov Identifier: NCT02903524
Recruitment Status : Unknown
Verified September 2016 by Hebei Medical University Fourth Hospital.
Recruitment status was:  Recruiting
First Posted : September 16, 2016
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
Hebei Medical University Fourth Hospital

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Doxorubicin Hydrochloride Liposome injection and cyclophosphamide Drug: pirarubicin and cyclophosphamide Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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



Primary Outcome Measures :
  1. pathological complete response [ Time Frame: until the completion of 4 cycles (each cycle is 21 days) of chemotherapy ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02903524


Contacts
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Contact: Geng Cuizhi, archiater 0311-66696310 gengcuizhi@hotmail.com

Locations
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China, Hebei
Fourth Hospital of Hebei Medical University Recruiting
Shi Jiazhuang, Hebei, China, 050019
Contact: Geng Cuizhi, archiater    0311-66696310    gengcuizhi@hotmail.com   
Sponsors and Collaborators
Hebei Medical University Fourth Hospital

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Responsible Party: Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier: NCT02903524     History of Changes
Other Study ID Numbers: CSPC-DMS-BC-03
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Pirarubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors