breast cancer
Conditions
Interventions
Experimental group:trastuzumab + pyrotinib + Dalpiciclib
Control group:trastuzumab + pyrotinib + chemotherapy
Sponsors
Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Untreated female patients aged >=18 years and 2 cm in diameter as determined by standard evaluation methods -Tumor stage: early stage (T1-3, N0-2, M0) 4. Breast cancer with HER2 expression positive confirmed by pathological examination Defined as >10% of the immunoreactive cells with an immunohistochemical (IHC) score of 3+ or in situ hybridization (ISH) results of HER2 gene amplification (HER2-based signal to centromere 17 signal ratio = 2.0 or HER2 gene copy number >=6). 5. Known hormone receptor status (ER and PgR) negative; 6. The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks before screening, no use of leukocytotropic or platelet-enhancing drugs) : 1) Blood routine Neutrophil (ANC) >=1.5×10^9/L; Platelet count (PLT) >=90×10^9/L; Hemoglobin (Hb) >=90 g/L; 2) Blood biochemistry Total bilirubin (TBIL) =55%; 4) 12-lead electrocardiogram Fridericia's corrected QT interval (QTcF) is < 470 msec; 7. For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment; 8. Voluntarily participate in this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer; 2. Inflammatory breast cancer; 3. Previously received antitumor therapy or radiation therapy for any malignancies, excluding cured cervical primary carcinoma, basal cell carcinoma or squamous cell carcinoma; 4. Also receive antitumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy; 5. Had a major non-breast cancer-related surgery in the 4 weeks prior to randomization, or had not fully recovered from such surgery; 6. Serious heart disease or discomfort, including but not limited to the following: History of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher grade atrioventricular block (i.e. Mobitz II second-degree atrioventricular block or third-degree atrioventricular block) - Angina pectoris that requires treatment with anti-angina medication -- valvular heart disease of clinical significance --ECG showed transmural myocardial infarction Poor hypertension control (systolic > 180 mmHg and/or diastolic > 100 mmHg) 7. Inability to swallow, intestinal obstruction, or other factors affecting drug use and absorption; 8. Known allergic history of the drug components of this protocol; A history of immunodeficiency, including HIV testing positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; 9. Pregnant and lactating women, fertile women who tested positive for baseline pregnancy tests, or women of childbearing age who were unwilling to use effective contraception throughout the trial period and within 7 months after the last study; 10. Have a serious concomitant medical condition or other comorbidities that would interfere with 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 |
|---|---|
| pCR,Pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| RCB,residual cancer burden;ORR,Objective response rate;Ki67 change;bpCR;EFS,event free survival;safety; | — |
Countries
China
Contacts
Public ContactWang Shouman,Xiao Zhi
Xiangya Hospital, Central South University
Outcome results
None listed