breast cancer
Conditions
Interventions
Group 1:Doxorubicin Hydrochloride Liposome+Cyclophosphamide+albumin-bound paclitaxel
Group 2:Doxorubicin Hydrochloride Liposome+Cyclophosphamide+albumin-bound paclitaxel
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 70 years old, female; 2) Patients with newly diagnosed primary breast cancer confirmed by histopathology with clinical stage IIA~IIIA; 3) Immunohistochemistry (IHC) detection of ER, PR, HER-2 were negative, if HER-2 expression of 2+ patients need to be confirmed by in situ hybridization detection of HER-2 gene without amplification; 4) According to the RECIST 1.1 standard, there is at least one measurable objective lesion with a tumor diameter > 2 cm; 5) ECOG fitness score 0-1 points; 6) LVEF = 55%; 7) Bone marrow function: neutrophils = 1.5 × 10^9/L, platelets = 100 ×10^9/L, hemoglobin = 90g/L; 8) Liver and kidney function: serum creatinine = 1.5 times the upper limit of normal; AST and ALT = 2.5 times the upper limit of normal; total bilirubin = 1.5 times the upper limit of normal, or patients with Gilbert's syndrome = 2.5 times the upper limit of normal; 9) The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) Cytotoxic chemotherapy, endocrine therapy or radiation therapy for any reason; 2) New York Heart Association (NYHA) score identifies patients with heart disease above grade II (including grade II); 3) Patients with severe systemic infections or other serious illnesses; 4) Patients known to be allergic or intolerant to chemotherapeutic drugs or their excipients; 5) Combined with other malignant tumors or had malignant tumors other than breast cancer in the past 5 years, except for cutaneous basal cell carcinoma, squamous cell carcinoma and cervical carcinoma in situ that have been fully treated and controlled; 6) Women of childbearing age who are pregnant or lactating and who refuse to take appropriate contraceptive measures during the trial; 7) Participated in other experimental studies within 30 days before the first dose of study drug administration 8) The investigator judges patients who are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease-free survival;breast conservation rate;safety; | — |
Countries
China
Contacts
Public ContactZhong Ouyang
The First Affiliated Hospital of Xiamen University
Outcome results
None listed