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
- 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
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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of liposomal doxorubicin in neoadjuvant breast cancer therapy?
How does the efficacy of liposomal doxorubicin compare to pirarubicin in locally advanced breast cancer treatment?
Which biomarkers correlate with response to anthracycline-based neoadjuvant chemotherapy in breast cancer patients?
What are the cardiotoxicity profiles of liposomal doxorubicin versus pirarubicin in breast cancer patients?
Are there alternative anthracycline formulations with improved therapeutic indices for locally advanced breast cancer?
Trial Locations
- Locations (1)
Fourth Hospital of Hebei Medical University
🇨🇳Shi Jiazhuang, Hebei, China
Fourth Hospital of Hebei Medical University🇨🇳Shi Jiazhuang, Hebei, ChinaGeng Cuizhi, archiaterContact0311-66696310gengcuizhi@hotmail.com