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

Phase 4

• Conditions: Breast Cancer
• Interventions: Drug: pirarubicin and cyclophosphamide; Drug: Doxorubicin Hydrochloride Liposome injection and cyclophosphamide

• Registration Number: NCT02903524
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-15
• Last Update Submitted: 2016-09-15
• Study First Posted: 2016-09-16
• Last Update Posted: 2016-09-16
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	pirarubicin and cyclophosphamide	Pirarubicin combination with cyclophosphamide,4 cycles (each cycle is 21days) of chemotherapy
Experimental group	Doxorubicin Hydrochloride Liposome injection and cyclophosphamide	Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide, 4 cycles (each cycle is 21 days) of chemotherapy

Primary Outcome Measures

Name	Time	Method
pathological complete response	until the completion of 4 cycles (each cycle is 21 days) of chemotherapy

Trial Locations

Locations (1)

Fourth Hospital of Hebei Medical University; 🇨🇳 Shi Jiazhuang, Hebei, China