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
Drug: Doxorubicin Hydrochloride Liposome injection and cyclophosphamide
Drug: pirarubicin and cyclophosphamide
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Full eligibility criteria for NCT02903524
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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.
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.
All locations for NCT02903524
Fourth Hospital of Hebei Medical University
Shi Jiazhuang, Hebei, China, 050019
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Tris trial is registered with FDA with number: NCT02903524. The sponsor of the trial is Hebei Medical University Fourth Hospital and it is looking for 300 volunteers for the current phase.
Official trial 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
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