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

Hebei Medical University

Status and phase: Unknown; Phase 4

Conditions: Breast Cancer

Treatments: Drug: Doxorubicin Hydrochloride Liposome injection and cyclophosphamide; Drug: pirarubicin and cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT02903524

CSPC-DMS-BC-03

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

control group

Active Comparator group

Description:

Pirarubicin combination with cyclophosphamide,4 cycles (each cycle is 21days) of chemotherapy

Treatment:

Drug: pirarubicin and cyclophosphamide

Experimental group

Experimental group

Description:

Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide, 4 cycles (each cycle is 21 days) of chemotherapy

Treatment:

Drug: Doxorubicin Hydrochloride Liposome injection and cyclophosphamide