breast cancer
Conditions
Interventions
Case series:pyrrotinib combined with trastuzumab plus paclitaxel combined with cisplatin
Sponsors
Breast center of Jiangxi Tumor Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients with primary treatment aged 18 to 75 years old; 2. ECOG score 0-1; 3. Breast cancer met the following criteria: histologically confirmed invasive breast cancer, the diameter of the primary tumor determined by the standard evaluation method in the research center was > 2cm;Tumor stage: early stage (t2-3, n0-1, M0) or local stage (t2-3, N2 or N3, M0); 4. Her2-positive breast cancer confirmed by pathological examination (HER2/CEP17 is greater than 2.0 and the average copy number of HER2/ cells is greater than 4.0); HER2/CEP17 is more than 2.0 and the average copy number/cell of HER2 is less than 4.0. The continuous section of the same specimen evaluated by ISH is IHC3+.HER2/CEP17 < 2.0 and HER2 copy number/cells of average HER2 < 4.0 were assessed as IHC3+ by successive sections of the same specimen from ISH; 5. Known hormone receptor status (ER and PR); 6. The functional level of the main organs must meet the following requirements (no blood transfusion or drugs for raising white blood cells or platelets were used in the first 2 weeks of screening): 1) blood routine: neutrophils (ANC) greater than or equal to 1.5 x 10^9/L;Platelet count (PLT) greater than or equal to 90 x 10^9/L;Hemoglobin (Hb) is greater than or equal to 90 g/L; 2) blood biochemistry: total bilirubin (TBIL) is less than or equal to the upper limit of normal value (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are less than or equal to 1.5 * ULN.Alkaline phosphatase is less than or equal to 2.5 times ULN;Urea nitrogen (BUN) and creatinine (Cr) less than or equal to 1.5 * ULN; 3) cardiac color doppler ultrasound: LVEF is greater than or equal to 55%; 4) 12-lead ecg: the QT interval (QTcF) < 470 msec corrected by Fridericia method; 7. For female patients without menopause or surgical sterilization: during the treatment period and at least 7 months after the last drug administration in the study treatment, they agree to abstain from sex or use effective contraception; Voluntary participation in this study, the signing of informed consent, good compliance and willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. A history of diagnosis of serious heart disease or discomfort, including but not limited to: heart failure or systolic dysfunction (LVEF 100 BPM, significant ventricular arrhythmia (such as ventricular tachycardia) or higher level of atrioventricular block (i.e., Mobitz II grade II or grade iii atrioventricular block); Angina pectoris requiring antiangina medication;Valvular heart disease of clinical significance; ECG showed transmural myocardial infarction.Poor control of hypertension (systolic > 180 mmHg and/or diastolic > 100 mmHg); 2. Inability to swallow, intestinal obstruction or other factors affecting drug use and absorption; 3. Those who are known to have allergy history to the drug components of this program;A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 4. Women in pregnancy and lactation, women with fertility and positive results in the baseline pregnancy test, or women of reproductive age who are unwilling to take effective contraceptive measures during the whole trial and within 7 months after the last study; Have a serious concomitant disease or any other concomitant disease that interferes with the planned treatment, or any other condition in which the investigator considers the patient unfit to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tpCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS;EFS;DDFS;ORR; | — |
Contacts
Public ContactZhengkui Sun
Breast center of Jiangxi Tumor Hospital
Outcome results
None listed