Triple Negative Breast Cancer
Conditions
Interventions
treatment group:LBP combined with taxino
control group:Carboplatin and paclitaxel
Sponsors
Fourth Hospital of Hebei Medical Uniwersity Tumor Hospital of Hebei Province
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old, female; 2. Confirmed by histopathology as breast cancer; 3. Immunohistochemical display: ER negative, PR negative, Her-2 is -/+, if ++, further FISH test confirmed the amplification of Her-2 gene; 4. The clinical stage is stage IIA-IIIC patients and there are neoadjuvant chemotherapy indications; 5. Measurable primary breast lesions (according to RECIST v1.1); 6. Physical condition ECOG PS: 0-1; 7. First treatment; 8, Laboratory tests meet the following criteria: Bone marrow function: blood neutrophils (ANC) absolute count = 1.5 × 10^9/L; platelets (PLT) = 100×10^9/L; hemoglobin (HB) = 90g/L; Liver function: serum total bilirubin (STB), bound bilirubin (CB) = normal upper limit (ULN)×1.5; alanine aminotransferase (ALT), aspartate aminotransferase (AST) =ULN×2.5; Kidney function: serum creatinine (Cr) = ULN; endogenous creatinine clearance (Ccr) = 60 ml/min (calculated using the Cockcroft-Gault formula); 9. Contraception during the study period and within six months of treatment; 10. The patient volunteered and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. During the first 4 cycles of the operation, major operations or surgical wounds have not yet been healed; 2. In the past 5 years, there were other malignancies originated from histology, except for adequately treated cervical carcinoma in situ and basal cell carcinoma or squamous cell carcinoma of the skin; 3. serious cardiovascular disease, including internal medicine treatment of uncontrolled hypertension (BP > 160/95mmHg), unstable angina pectoris, the history of myocardial infarction in the past June, >NYHA II of congestive heart failure, serious arrhythmia and pericardial effusion, etc.; 4. Serious infection requires intravenous antibiotics, antifungal or antiviral treatment; 5. Suffering from mental illness and poor compliance; The researchers believe that it is not suitable for the case of group entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| RFS;ORR;Relationship between DNA damage repair homologous recombination genome and platinum efficacy; | — |
Countries
China
Contacts
Public ContactYun-Jiang Liu
Fourth Hospital of Hebei Medical Uniwersity Tumor Hospital of hebei Province
Outcome results
None listed