breast cancer
Conditions
Interventions
Test group:In the first stage, after receiving 4 cycles of neoadjuvant therapy with dalpiciclib combined with letrozole, the imaging evaluation showed PR/CR (RECIST 1.1), and continued to complete 2 c
If assessed as SD (RECIST 1.1) through imaging, receive 4 cycles of neoadjuvant therapy with Trastuzumab Deruxtecan for Injection (SHR-A1811).
Sponsors
Anyang Tumor Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Postmenopausal or premenopausal/perimenopausal women aged = 18 years and =75 years old must receive LHRH agonist therapy during the study; 2. Pathological examination confirmed the diagnosis of invasive breast cancer with low expression of HR+/HER2; Estrogen receptor (ER) positive (>10%), progesterone receptor (PR) positive (>1%), HER2 low expression. Immunohistochemistry (IHC) score of 1+, or 2+ with negative in situ hybridization (ISH) test confirmed by the pathology laboratory; 3. ECOG score 0~1 points; 4. Patients with stage II-III breast cancer whose tumor stage meets the criteria of the 8th edition of AJCC, and the tumor stage is early (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0); 5. Normal function of major organs, that is, meet the following standards: (1) Blood routine examination standards must meet: ANC >=1.5×10^9/L; PLT >=90×10^9/L; Hb >= 90g/L; (2) Biochemical examination must meet the following criteria: TBIL =upper limit of normal (ULN); ALT and AST=50 mL/min (CockcroftGault formula); (3) Cardiac color ultrasound and echocardiography: left ventricular ejection fraction (LVEF>=55%); (4) 18-lead ECG corrected by Fridericia's QT interval (QTcF) in women< 470 ms; 6. For female patients who are not menopausal or surgically sterilized: agree to abstain from sexual activity or use effective contraceptive methods during treatment and for at least 7 months after the last dose of study treatment; Premenopausal or perimenopausal patients (if this is the case, combined with OFS, OFS includes bilateral oophorectomy or GnRHa drugs), or postmenopausal patients. 7. Voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.); Excluding cured malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma; 2. Stage IV (metastatic) breast cancer; 3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer; 4. Breast cancer that has not been diagnosed by histopathology; 5. Other malignant tumors have occurred within the past 5 years, except for cured cervical carcinoma in situ; 6. Severe heart, liver and kidney and other important organ dysfunction; 7. Severe heart disease or discomfort, including but not limited to the following diseases: Confirmed history of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmias (eg, ventricular tachycardia), or higher grade atrioventricular block (i.e., Mobitz II second-degree atrioventricular block or third-degree atrioventricular block) Angina requiring antianginal medication Clinically significant valvular heart disease ECG shows transmural myocardial infarction Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg) 8. Inability to swallow, chronic diarrhea and intestinal obstruction, and there are many factors affecting drug intake and absorption; 9. Those who are known to have a history of allergy to the drug components of this plan; History of immunodeficiency, including positive HIV test, HCV, active viral hepatitis B, or other acquired, congenital immunodeficiency disease, or history of organ transplantation; 10. Pregnant and lactating female patients, female patients of childbearing potential with positive baseline pregnancy test test or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and within 7 months after the last study drug; 11. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, etc. that cannot be controlled by drugs); 12. Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia. Any other condition that the investigator considers the patient unsuitable for participation in this study. 13. Participated in other drug clinical trials within 4 weeks before enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective response rate (ORR) evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1); | — |
Secondary
| Measure | Time frame |
|---|---|
| pathologic complete response;Complete remission rate of breast pathology;Residual cancer burden 0-I;disease control rate;Event free survival period;Disease-free survival period; | — |
Countries
China
Contacts
Public ContactYuan Shi
Anyang Tumor Hospital
Outcome results
None listed