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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hebei Medical University Fourth Hospital
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Pirarubicin

Criteria

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.