Breast Cancer
Conditions
Interventions
treatment group: disitamab vedotin plus dalpiciclib and exemestane
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Participants voluntarily join this study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up visits; 2. Newly diagnosed female, age: 18-70 years old (at the time of signing the informed consent form): ECOG score: 0 to 1 points; 3. Breast cancer pathological results meet the following criteria: Pathological diagnosis confirmed as ER positive and HER2 low expression invasive breast cancer. (The definition of ER positive expression is: Standard immunohistochemistry (IHC) test is ER(+, 1%). The definition of HER2 low expression is: Standard IHC test is 1+, 2+/FISH-). This study only selects patients with ER expression greater than 10% and HER2 low expression. 4. Histologically confirmed invasive breast cancer, with the primary tumor diameter > 2 cm measured by standard assessment methods at the research center; Tumor staging: Locally advanced (Stage ?B-?C, i.e., T2N1M0, T0-2N2M0, T3N0-2M0, T4N0-2M0) 5. Postmenopausal or perimenopausal premenopausal female patients are eligible for enrollment, but premenopausal or perimenopausal patients must be willing to receive LHRH agonist treatment during the study period. 6. The main organ function levels must meet the following requirements (no blood transfusion within 2 weeks before screening, and no use of white blood cell or platelet-raising drugs): (1) Blood routine: Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count (PLT) >=90×10^9/L; Hemoglobin (Hb) >=90 g/L; (2) Blood biochemistry: Total bilirubin (TBIL) =50%; (4) For premenopausal or non-surgical sterilized female patients: Agree to abstain or use effective contraceptive methods (such as intrauterine device, oral contraceptives, or condoms) during the treatment period and at least 6 months after the last administration of study treatment; Negative serum pregnancy test within 7 days before study enrollment, and must be non-lactating participants.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer; 2. Previously received anti-cancer treatment or radiotherapy for any malignant tumor, excluding cured in situ cervical cancer, basal cell carcinoma, or squamous cell carcinoma, etc.; 3. Concurrently receiving anti-cancer therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy; 4. Received major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgery; 5. Severe cardiac disease or discomfort, including but not limited to the following conditions: a 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 requiring anti-anginal drug treatment; clinically significant valvular heart disease; ECG showing transmural myocardial infarction; poorly controlled hypertension (systolic pressure > 180 mmHg and/or diastolic pressure > 100 mmHg); 6. Inability to swallow, intestinal obstruction, or other factors affecting drug intake and absorption; 7. Known history of allergy to any component of the study drugs; a history of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 8. Pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test, or women of reproductive age unwilling to use effective contraception during the entire trial period and for 7 months after the last administration of the study drug; 9. Patients with severe concurrent diseases or other conditions that would interfere with the planned treatment, or any other circumstances that the investigator deems unsuitable for the patient to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| breast pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological complete response;complete cell cycle arrest;clinical response rate;event-free survival;overall survival;breast conservation rate; | — |
Countries
China
Contacts
Public ContactOuchen Wang
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed