breast cancer
Conditions
Interventions
Case series:pyrotinib maleate tablets combined with albumin paclitaxel combined with epirubicin and cyclophosphamide
Sponsors
The First Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 ~70 years; 2. ECOG PS: 0-1; 3. Breast cancer meets the following criteria: histologically confirmed invasive breast cancer, primary tumor diameter > 2 cm as determined by standard evaluation methods in the center -- tumor stage: early (t2-3, n0-1, M0) or locally advanced (t2-3, N2, or N3, M0); 4. Breast cancer with positive HER2 expression confirmed by pathological tests was defined as >10% immunoreactive cells with 3+ immunohistochemical (IHC) fraction or in situ hybridization (ISH) result of HER2 gene amplification (ratio of HER2 basal signal to centromeres 17 signal >= 2.1 or HER2 gene copy number >= 6). 5. Known hormone receptor status (ER and PR); 6. The functional level of the main organs must meet the following requirements (no blood transfusions within 2 weeks prior to screening, no use of leukocyte or platelet-elevating drugs): 1) ANC >= 1.5 x 10^9/L; PLT >= 90 x 10^9/L; Hb >= 90 g/L; 2) TBIL= 55%; 4) 12-lead ecg: QT interval (QTcF) corrected by Fridericia method < 470 msec; 7. Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 weeks after the last given Apatinib. For male, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 weeks after the last given Apatinib. 8. Subjects voluntarily participated in this study, signed informed consent, followed up with good compliance.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer; 2. Inflammatory breast cancer; 3. Previous anti-tumor treatment or radiotherapy for any malignant tumor, excluding cured malignant tumors such as cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma; 4. Receive antitumor therapies, including endocrine therapy, bisphosphonates or immune-free therapies, in other clinical trials; 5. Patients who had undergone major surgical operations not related to breast cancer within 4 weeks prior to enrollment, or who had not fully recovered from such operations; 6. History of severe heart disease or discomfort, including but not limited to: history of diagnosed heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmias (e.g. Angina pectoris requiring antiangina medication; Valvular heart disease with clinical significance; The ECG showed a transmural myocardial infarction. Poor hypertension control (systolic blood pressure >180mmHg and/or diastolic blood pressure > 100 mmHg); 7. Inability to swallow, intestinal obstruction or other factors affecting the administration and absorption of drugs; 8. A history of allergy to the drug components of the regimen is known; A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency, or a history of organ transplantation; 9. Female patients who are pregnant or breastfeeding; Persons with fertility who are unwilling or unable to take effective contraceptive measures; 10. Severe concomitant illness or other comorbidity that may interfere with treatment, or any other condition in which the investigator considers the patient to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| EFS;DFS;DDFS;ORR;safety; | — |
Countries
China
Contacts
Public ContactZhao Da
The First Hospital of Lanzhou University
Outcome results
None listed