breast cancer
Conditions
Interventions
single arm:PLD combined with trastuzumab and paclitaxel
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. aged over 18 years old female; 2. patients with stage II-III HER2 positive breast cancer confirmed by pathology and immunohistochemistry; 3. no relevant treatment (such as antitumor therapy, immunotherapy, related operation, etc.) was possible before treatment; 4. according to the RECIST standard, the lesion can be measured (the length of the primary tumor is more than 1.0cm or the lymph node diameter is shorter than 1.5cm); 5. ECOG PS score: 0-2 points; 6. the main organs are functioning normally, that is, they meet the following criteria: (1) white blood cells were more than 4*10^9/L, and neutrophil count (ANC) was more than 1.5*10^9/L; (2) the platelet is more than 100*10^9/L; (3) the hemoglobin is more than 10g/dL; (4) the upper limit of serum creatinine < 1.5 * normal value (ULN); (5) aspartate aminotransferase (AST) is less than 2.5 x ULN; (6) alanine aminotransferase (ALT) is less than 2.5 x ULN; (7) total bilirubin is less than 1.5 x ULN; serum creatinine is less than 1.5 * ULN; 7. the volunteers voluntarily joined the study, signed informed consent, and had good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. pregnant and lactation patients; 2. patients with peripheral nervous system disorders caused by diseases or those with obvious mental disorders and central nervous system disorders; 3. patients with severe infection or active gastrointestinal ulcer need treatment; 4. allergic to chemotherapeutic drugs or surgical contraindications; 5. in addition to cured basal cell carcinoma and cured cervical cancer in situ, other cancer free periods are less than 5 years; 6. severe liver diseases such as cirrhosis, cardiovascular disease, kidney disease, respiratory disease or diabetes that can not be controlled; 7. patients who are taking part or participating in other clinical trials within one month; 8. previous history of severe cardiovascular disease or cardiovascular disease risk factors were more than 4.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart safety;DFS;OS;ORR; | — |
Countries
China
Contacts
Public ContactFEI MA
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed