HER2-DM-NACTTrastuzumab, Pyrotinib, and Paclitaxel for HER2-Positive Breast Cancer
Patients will initially receive trastuzumab, pyrotinib, and albumin-bound paclitaxel. Those who do not achieve a radiological response after Cycle 2 will switch to SHR-A1811 (a HER2-targeted antibody
+ Patients will initially receive trastuzumab, pyrotinib, and nab-paclitaxel. Those who achieve a partial response (PR) or complete response (CR) after cycle 2 will continue on the same regimen.
Treatment Study
Summary
Study start date: September 1, 2025
Actual date on which the first participant was enrolled.This study focuses on improving treatment for patients with HER2-positive breast cancer, a type of cancer that tests positive for a protein called human epidermal growth factor receptor 2. The goal is to enhance the effectiveness of pre-surgery treatments by using a method that adjusts the treatment based on how well the cancer is responding. Patients initially receive a combination of trastuzumab, pyrotinib, and albumin-bound paclitaxel. If the cancer does not show improvement after two treatment cycles, the therapy switches to SHR-A1811 and pertuzumab. This approach aims to increase the rate of complete cancer disappearance from the breast tissue before surgery while ensuring treatments remain safe and tolerable. Participants in the study will start with an oral or intravenous treatment regimen and undergo regular imaging tests to see how the cancer is responding. If the initial treatment doesn't shrink the cancer, the medication is adjusted to potentially more effective drugs. The study measures success by looking at the pathological complete response rate, which indicates how much of the cancer is eliminated by the treatment. The study also monitors for any side effects to ensure that the treatments are safe for patients. This dynamic approach could lead to more personalized and effective cancer care, potentially improving outcomes for those affected by HER2-positive breast cancer.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: 1. Histologically confirmed invasive cancer of the breast and meet the clinical stage II（T2N0-1M0/T3N0M0）or III（T2N2M0/T3N1-2M0) criteria; 2. Age between18-70 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 4. Histologically confirmed to be HER2-positive invasive breast cancer; 5. LVEF≥55%； 6. At least one measurable lesion according to RECIST version 1.1 7. Normal organ and marrow function: Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \< 1 x ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula); 8. Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug; Ability to understand and willingness to sign a written informed consent Exclusion Criteria: 1. Stage IV (metastatic) breast cancer. 2. The patient has a second primary malignant tumor, except for fully treated skin cancer. 3. The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures. 4. The presence of uncontrolled cardiovascular and cerebrovascular disease, including (but not limited to) any of the following within the 6 months prior to the first dose: congestive heart failure (NYHA III or IV), myocardial infarction or cerebral infarction, pulmonary embolism, unstable angina, or arrhythmia requiring treatment at the time of screening; 5.Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restricted cardiomyopathy, undefined cardiomyopathy); A clinically significant history of prolonged QTc, grade II type II atrioventricular block or grade III atrioventricular block or QTc interphase (F method) \> 470 msec (female); Atrial fibrillation (EHRA grade ≥2b); Unmanageable hypertension, which the investigators judged unsuitable for study participation. 6.Individuals with a known history of allergies to the drug components of this protocol; 7.Having a history of immunodeficiency, including HIV testing positive, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives