HER2-negative breast cancer
Conditions
Interventions
Group 1:Neoadjuvant therapy and surgery
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. ECOG 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. Pregnancy-positive patients; 2. Have serious infectious diseases (hepatitis B, hepatitis C, etc.); 3. Left ventricular ejection fraction is less than 50% or previously diagnosed as heart failure during the screening period; 4. Chronic diseases such as uncontrolled hypertension or diabetes; 5. Any prior treatment (chemotherapy, hormone therapy, radiation therapy, etc.); 6. Major surgery has been performed within 4 weeks before the start of study treatment and has not fully recovered; 7. Arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism, have occurred within 1 year before study treatment; 8. Known hypersensitivity or delayed allergic reaction to epirubicin, PLD, docetaxel, certain components of cyclophosphamide or similar drugs; 9. Abnormal laboratory test results: hemoglobin (Hb) 2.5 x ULN (if the liver is involved, ALT, AST > 5 x ULN); serum creatinine (Cr) >1.5 x ULN; total bilirubin (TBIL) > 1.5 x ULN; 10. 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 |
|---|---|
| cardiotoxity;Health-related quality of life score ;the rate of breast conserving surgery;pathologic complete response ;disease free survival ;objective remission rate ;overall survival; | — |
Countries
China
Contacts
Public ContactZhang Jianguo
The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed