Early or locally advanced breast cancer with low estrogen receptor expression (ER <10%) and low HER2 expression, defined as immunohistochemistry (IHC) 1+, or IHC 2+ with no amplification detected by in situ hybridization (ISH).
Conditions
Interventions
Control group:Conventional neoadjuvant chemotherapy
Treatment group:Trasturzrmb Rezetean(SHR-A1811) combined with camrelizumab, sequentially followed by docetaxel and carboplatin combined with camrelizumab
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age >=18 years and <=70 years; 2.Histopathologically confirmed invasive breast cancer; 3.Histopathologically confirmed breast cancer with low estrogen receptor expression (ER <10%) and low HER2 expression [defined as immunohistochemistry (IHC) 1+, or IHC 2+ with no amplification detected by in situ hybridization (ISH)]; 4.Treatment-naïve breast cancer patients with tumor staging according to the 8th edition of AJCC breast cancer staging criteria: clinical stage T1cN1-2M0, or T2-3N0-2M0; 5.At least one measurable target lesion according to RECIST v1.1; 6.ECOG performance status score of 0–1; 7.Adequate function of vital organs (no correction treatment with any blood components or cell growth factors within 14 days prior to the first dose); 8.For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment and must be negative; patients must be non-lactating; all enrolled patients must adopt adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion; 9.Voluntarily agree to participate in this study, sign informed consent, have good compliance, and be willing to comply with follow-up visits and study-related procedures.
Exclusion criteria
Exclusion criteria: 1.Breast cancer not confirmed by histopathology; 2.Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer; 3.Diagnosis of another malignancy within the past 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ; 4.Use of immunosuppressive agents or systemic hormone therapy for immunosuppressive purposes within 2 weeks prior to the first dose (dose >10 mg/day of prednisone or equivalent physiological doses of other corticosteroids), excluding nasal or inhaled corticosteroids; 5.Receipt of live or attenuated vaccines within 4 weeks prior to the first dose; 6.Major surgery unrelated to breast cancer within 4 weeks prior to the first dose, or not fully recovered from such surgery; 7.Presence of any active autoimmune disease or history of autoimmune disease with potential for relapse [including but not limited to: autoimmune hepatitis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects controlled with hormone replacement therapy only may be included)]; subjects with skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia), controlled type I diabetes mellitus managed with insulin therapy, or childhood asthma that has completely resolved and requires no intervention in adulthood may be included; asthmatic patients requiring medical intervention with bronchodilators are excluded; 8.History of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 9.Presence of uncontrolled or significant cardiovascular or cerebrovascular disease, including (but not limited to): any of the following occurring within 6 months prior to the first dose – congestive heart failure (NYHA class III or IV), myocardial infarction or cerebral infarction (excluding lacunar infarction), pulmonary embolism, unstable angina, or arrhythmia requiring treatment at screening; primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy); history of clinically significant QTc prolongation, second-degree type II atrioventricular block, third-degree atrioventricular block, or QTcF >470 msec (female); atrial fibrillation (EHRA grade =2b); uncontrolled hypertension that the investigator deems makes the subject unsuitable for study participation; 10.Subjects with known or suspected interstitial lung disease; presence within 3 months prior to the first dose of other moderate-to-severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity or seriously affect respiratory function, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/obliterative bronchiolitis, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), obstructive/restrictive lung disease, etc.; and any autoimmune, connective tissue, or inflammatory disease involving the lungs, such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc., or previous total pneumonectomy; 11.Presence of active hepatitis B (HBsAg positive and HBV DNA >=500 IU/mL), hepatitis C (HCV antibody positive and HCV RNA above the upper limit of normal range), or cirrhosis; or severe infection requiring control with antibiotics, antivirals, or antifungal agents; 12.Known inherited or acquired bl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety outcome;Change in Ki-67 index;Objective response rate;Breast-conserving rate (BCR);Event-Free Survival (EFS); | — |
Countries
China
Contacts
Public ContactZhang Wei
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed