HER2-negative breast cancer
Conditions
Interventions
Experimental group:PLD + cyclophosphamide
Control group:Epirubicin + cyclophosphamide
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Histopathologically diagnosed as unilateral or bilateral HER2-negative, invasive breast cancer; 2. Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathological inflammatory cancer or regional stage IV, where supraclavicular lymph nodes are the only sites of metastasis ; 3. At least one measurable lesion according to RECIST 1.1 criteria; 4. Aged 18 to 80 years; 5. COG score <= 2 points; 6. No previous history of malignant tumor and no concurrent occurrence of other tumors; 7. Patients or their legal representatives must provide written informed consent prior to any research-specific examinations or procedures; 8. Able to understand trial requirements, willing and able to comply with trial and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with serious infectious diseases; 2. Any prior treatment (chemotherapy, hormone therapy, radiation therapy, etc.); 3. Major surgery has been performed within 4 weeks before the start of study administration and has not fully recovered; 4. Arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism, occurred within 1 year before study administration; 5. HIV test result is positive; 6. Known to have hypersensitivity or delayed allergic reaction to epirubicin, PLD, docetaxel, certain components of cyclophosphamide or similar drugs; 7. Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response;Health-related quality of life score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival;The rate of breast conserving surgery;Objective remission rate;Overall survival;Adverse events; | — |
Countries
China
Contacts
Public ContactZhang Jianguo
The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed