breast cancer
Conditions
Interventions
Case series:pegylated liposomal doxorubicin/docetaxel/Trastuzumab
Sponsors
Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Ability to understand and voluntarily receive the research procedures according to protocol,willingness to sign the written informed consent document; 2. Female patients aged from 18 to 70 years old; 3. Histologically confirmed as invasive breast cancer. occult breast cancer, inflammatory breast cancer and eczematoid carcinoma are ineligible; 4. Clinical stage II-III; 5. HER-2 Positive (defined by: IHC 3+ or ISH positive); 6. Without previous treatment for this breast cancer; 7. Patients must have at least one measurable disease according to RECIST 1.1; 8. ECOG (Eastern Cooperative Oncology Group) performance score of 0-1 points; 9. LVEF=55%; 10. Normal ECG; 11. Bone marrow function:absolute neutrophil count (ANC)=2.0×109/Lplatelets=100×109/Lhemoglobin =90g/L; 12. Hepatic functionalanine aminotransferase(ALT) and aspartate aminotransferase(AST) =1.5×ULNserum total bilirubin= ULN; 13. Renal functionserum creatinine=1.5×ULN; 14. Coagulation functionthe international standardized ratio (INR) =1.5×ULN, prothrombin time (PT) or the activated partial thrombin time (APTT) =1.5×ULN.
Exclusion criteria
Exclusion criteria: 1. New York Heart Association (NYHA) class =II heart failure; 2. Known or suspected hypersusceptibility to any agents used in the treatment protocol; 3. Need to Concurrent treatment with any other anti-cancer therapy considered by the investigator; 4. participating in other clinical trials within 4 weeks before this study; 5. History of cardiac diseasee.g., arrhythmias, conduction block, ST-segment elevation, ischemic or congenital heart disease, or other cardiac risk factors (high blood pressure and diabetes requiring medication); 6. Severe or uncontrolled infection; 7. Hepatitis b surface antigen positive, or hepatitis c virus antibody positive, or human immunodeficiency virus (HIV) antibody positive; 8. Active malignancy, other than adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skinwithin the past 5 years; 9. Women who are pregnant , breastfeeding ,or refuse to use adequate contraception prior to study entry and for the duration of study participation; 10. Other conditions considered to be inappropriate to be enrolled by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Breast conserving surgery;Rate of surgery;5-year overall survival rate;5-year disease-free Survival;Adverse events; | — |
Countries
China
Contacts
Public ContactZhenchuan Song
Fourth Hospital of Hebei Medical University
Outcome results
None listed