Breast cancer
Conditions
Interventions
Intervention group:Disitamab Vedotin
Sponsors
The First Affiliated Hospital of Army Medical University, PLA
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female breast cancer patients aged 18-75 years; 2. ECOG score 0-1 points; According to RECIST 1.1 standard, at least one measurable lesion exists; 4. The histopathological examination confirmed that HER2 expression was positive, and the clinical staging was stage II-III [cT2 and any N, cT3 and any N; cT4 and any N, according to the standards of the American Joint Commission on Cancer (AJCC)] invasive breast cancer patients. Note: Positive expression of HER2 refers to those who are detected as positive by the Pathology Department of the participating central hospital, and are defined as those with 3+immunohistochemical (IHC) detection results or HER2 gene amplification by in situ hybridization (ISH) results (HER2/CEP17>=2.0 or average HER2 copy number/cell>=6). 5. Patients who have previously used trastuzumab in combination with paclitazumab and chemotherapy for neoadjuvant therapy and have been evaluated as SD for their 4-cycle efficacy; 6. The hormone receptor status is known (ER and PgR); 7. Main organs function normally: A. Blood routine: Neutrophils (ANC)>=1.5 x 109/L; Platelet count (PLT)>=90 x 109/L; Hemoglobin (Hb)>=90 g/L; B. Blood biochemistry: Total bilirubin (TBIL)=50%; D.12 Lead ECG: The QT interval (QTcF) corrected by Fridericia method is<470 msec. Patients with negative serum pregnancy tests and potential fertility must agree to use effective non hormonal contraceptive methods during treatment and at least 6 months after the last use of the investigational drug. 9. Volunteer to participate in this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer; 2. Those who have previously received anti HER2 treatment drugs other than trastuzumab and patstuzumab; 3. Concurrently receiving anti tumor therapy in other clinical trials, including endocrine therapy, bisphosphate therapy, and immunotherapy; 4. The patient has undergone major surgical procedures unrelated to breast cancer within 4 weeks before randomization, or has not fully recovered from such surgical procedures; 5. Have other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma. 6. Serious heart disease or discomfort, including but not limited to the following diseases: A. A confirmed history of heart failure or systolic dysfunction (LVEF100 bpm, significant ventricular arrhythmia (such as ventricular tachycardia), or higher level atrioventricular block (such as Mobitz II second degree atrioventricular block or third degree atrioventricular block); C. Angina requiring treatment with anti angina drugs; D. Clinically significant valvular heart disease; E. ECG shows transmural myocardial infarction Poor control of hypertension (systolic blood pressure>180mmHg and/or diastolic blood pressure>100mmHg) 7. Persons with a known history of allergy to the drug components of this protocol; Have a history of immunodeficiency, including HIV testing positive, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 8. According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (including but not limited to severe hypertension beyond the control of drugs, severe diabetes, active infection, etc.). 9. Those who suffer from mental illness or abuse of psychotropic substances and are unable to cooperate with the research; 10. Pregnant or lactating female patients; 11. Any other circumstances that the researcher believes are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR (Objective Response Rate);DCR(Disease Control Rate);CBR(Clinical Benefit Rate);RCB (Residual Cancer Burden);iDFS(Invasive Disease-Free Survival);OS (Overall Survival); | — |
Countries
China
Contacts
Public ContactXiaowei Qi
The First Affiliated Hospital of Army Medical University, PLA
Outcome results
None listed