Overview

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.