Breast cancer
Conditions
Interventions
Experimental group:test drug for pyrotinib
Control group:No
Sponsors
Shengjing Hospital of China Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Female patients aged 18 to 75 years (The maximal age of the subjects enrolled in the Phase 3 study of pyrotinib is 75 years old, and there is no safety data for the use of the drug in older people); 2.ECOG level 0-1; 3.Primary infiltrating breast lesions and lymph nodes should follow these conditions at the same time: histologically confirmed invasive breast cancer; receiving neoadjuvant treatment and completing the operation, with postoperative pathological examination indicating residual invasive cancer in the breast or axillary lymph nodes; HER2-positive breast cancer is confirmed in the pathology test, with 3+ in immunohistochemistry (IHC) test and HER2 gene amplification (HER2/CEP17 >= 2.0 or average HER2 copy number/cell number >= 6); no recurrent and metastatic disease after surgery; 4.HER-2 positive breast cancer patients who have non-pCR after trastuzumab+pertuzumab as neoadjuvant therapy, and have completed trastuzumab combined with pertuzumab as adjuvant treatment. During the neoadjuvant and/or adjuvant therapy phase, at least >=24 weeks (8 drug delivery cycles) of trastuzumab + pertuzumab. And the time interval from the end of the last trastuzumab treatment to entering the trial must be = 1.5x10^9/L; (2)Platelet count (PLT) >= 90x10^9/L; (3)Hemoglobin (Hb) >= 90 g/L; (4)Total bilirubin (TBIL)<= 1.5xupper limit of normal (ULN); (5)Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 1.5xULN; 7.Female patients who are not menopausal or not surgically sterilized agree to abstain from sex or use effective non-hormonal drugs for contraception during the treatment period and within 8 weeks after the last administration; 8.Patients who participate in the trial?voluntarily, sign an informed consent, have good compliance and are willing to comply with the follow-up visit.
Exclusion criteria
Exclusion criteria: 1.With a history of recurrent local or regional breast disease; 2.Stage iv (metastatic) breast cancer; 3.Bilateral breast cancer; 4.With a history of any malignancies other than breast cancer in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma; 5.Patients who have received pyrotinib, lapatinib, neratinib or other tyrosine kinase inhibitors, enmetrastuzumab (T-DM1), and other anti-tumor biological therapies or tumor immunotherapy; 6.Patients who are receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy; 7.Severe heart disease or discomfort, including but not limited to the following diseases: a confirmed history of heart failure or systolic dysfunction (LVEF 180 mmHg and/or diastolic blood pressure > 100 mmHg); 8.Inability to swallow, intestinal obstruction or other factors that affect drug taking and absorption; 9.With a history of diagnosed neurological or mental disorders, including involuntary behavior or mental illness; 10.With a history of gastrointestinal diseases with diarrhea as the main symptom; 11.Patients who are known to have a history of allergies to the drug components in this trial; have a history of immunodeficiency, including HIV positive results, or other acquired or congenital immunodeficiency diseases; or have a history of organ transplantation; 12.Female patients during pregnancy and lactation, or those who are fertile and positive for baseline pregnancy test; 13.Serious concomitant diseases or other comorbid diseases that will interfere with the planned treatment, including infectious diseases with active infections (including but not limited to hepatitis B, active hepatitis C, active tuberculosis, active syphilis, etc.); or any other cases in which the investigator believes that the patient cannot participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive disease-free survival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival;Overall survival;Distant Disease-Free Survival; | — |
Countries
China
Contacts
Public ContactLiu Caigang
Shengjing Hospital of China Medical University
Outcome results
None listed