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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Doxorubicin Hydrochloride Liposome injection and cyclophosphamide
* Drug: pirarubicin and cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>Pirarubicin combination with cyclophosphamide,4 cycles (each cycle is 21days) of chemotherapy | Drug: pirarubicin and cyclophosphamide<br> <br> |
| Experimental: Experimental group<br>Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide, 4 cycles (each cycle is 21 days) of chemotherapy | Drug: Doxorubicin Hydrochloride Liposome injection and cyclophosphamide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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