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

Sponsor
Hebei Medical University Fourth Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02903524
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
27
Duration (Months)
11.1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Doxorubicin Hydrochloride Liposome injection and cyclophosphamide
  • Drug: pirarubicin and cyclophosphamide
 Phase 4

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. pathological complete response [until the completion of 4 cycles (each cycle is 21 days) of chemotherapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fourth Hospital of Hebei Medical University Shi Jiazhuang Hebei China 050019

Sponsors and Collaborators

  • Hebei Medical University Fourth Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier:
NCT02903524
Other Study ID Numbers:
  • CSPC-DMS-BC-03
First Posted:
Sep 16, 2016
Last Update Posted:
Sep 16, 2016
Last Verified:
Sep 1, 2016
Additional relevant MeSH terms:
Breast Neoplasms
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Pirarubicin

Study Results

No Results Posted as of Sep 16, 2016