breast cancer
Conditions
Interventions
Experimental group:New Adjuvant Therapy of Dalxil+Trastuzumab+Pyrrolidine+Letrozole
Sponsors
Yunnan Cancer Hospital and Affiliated Cancer Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18-75 years who are newly treated for breast cancer. 2. Premenopausal or perimenopausal patients (patients in this category should be combined with OFS, which include bilateral oophorectomy or GnRHa drugs), or postmenopausal patients. 3. Early or locally advanced ER+/HER2+ invasive breast cancer confirmed by histopathology, as defined in the latest ASCO/CAP guidelines, stage II-III. ER positive was defined as: the proportion of tumor cells with positive staining accounted for more than 10% of all tumor cells (reviewed and confirmed by investigators in the study center); HER2 positive definition: IHC 3+ or IHC2+ but ISH positive (reviewed and confirmed by the investigator at the study center). 4. ECOG score 0 to 1. 5. Expected survival is not less than 3 months. 6. At least one measurable lesion was present according to RECIST 1.1 criteria. 7. The functional level of the organ must meet the following requirements: (1) Blood routine: Neutrophil count (ANC)) >=1.5x10^9/L (no hematopoietic stimulating agents were used within 14 days prior to first administration), platelet count (PLT) >=100x10^9/L (no corrective therapy was used within 7 days prior to first administration), hemoglobin (Hb) >=90 g/L (no corrective therapy was used within 7 days prior to first administration); (2) Blood biochemistry: TBIL=50 mL/min (Cockcrod-Gault formula); (3) Cardiac function: 1) Cardiac color ultrasound: LVEF>=55%; 2) 12-lead ECG: QT interval corrected by Fridericia was < 470 msec. 8. Contraception: Fertile female patients must undergo a negative serum pregnancy test no more than 72 hours before the first dose and consent to use a highly effective, medically approved method of contraception during the study period and 90 days after the last dose of the study drug. 9. Participate in the study voluntarily, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with metastatic or bilateral breast cancer; 2. Patients with inflammatory breast cancer; 3. Received any antitumor therapy, including chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biotherapy or tumor embolization, within 12 months prior to signing the informed consent; 4. Other active malignant tumors within 5 years prior to signing the informed consent form or at the same time. Cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, cervical carcinoma in situ, etc., could be included in the group; 5. Had undergone major non-breast cancer related surgical procedures within 4 weeks prior to inclusion, or had not fully recovered from such surgical procedures (tissue biopsy and peripheral venipunction of central venous catheter for diagnostic purposes [PICC] were allowed); 6. Inability to swallow, chronic diarrhea and intestinal obstruction, with multiple factors affecting drug administration and absorption; 7. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); Active hepatitis B (defined as a positive HBV-surface antigen test and a positive HBV-DNA test); Hepatitis C (defined as HCV-RNA above the lower detection limit of analytical methods) or co-infection with hepatitis B and hepatitis C; Autoimmune hepatitis; 8. Serious heart disease or discomfort, including but not limited to: (1) A history of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or higher-grade atrioventricular block (i.e., Mobitz II second-degree atrioventricular block or third-degree atrioventricular block); (3) Angina pectoris requiring antiangina medication; (4) Valvular heart disease with clinical significance; (5) ECG showed transmural myocardial infarction; (6) Poor hypertension control (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg); 9. Severe infection within 4 weeks prior to the first medication (e.g., static treatment is required according to the clinical guidelines; Intravenous antibiotic, antifungal, or antiviral medication), or unexplained fever >38.5°C during screening/prior to initial administration; 10. Known allergic history of drug components or any excipients of this program; 11. Known history of allogeneic organ transplantation or allohematopoietic stem cell transplantation; 12. Lactating patients; 13. There is a clear history of neurological or psychiatric disorders, including epilepsy or dementia, and the subject has a known history of psychotropic substance abuse, alcoholism or drug use; 14. The investigator did not consider the patient suitable for any other conditions in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Survival without invasive disease; | — |
Countries
China
Contacts
Public ContactNie Jianyun, Wei Wei
Yunnan Cancer Hospital and Affiliated Cancer Hospital of Guangxi Medical University
Outcome results
None listed