Breast cancer
Conditions
Interventions
Treatment group:Topical Imiquimod Cream Combined with Aipalolitovorelizumab Plus Chemotherapy
Sponsors
The first affiliated hostipal of nanchang university
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Adult female patients (aged 18–75 years) with newly diagnosed breast cancer confirmed by pathology; 2.Pathologically confirmed triple-negative breast cancer (defined as: immunohistochemical results showing ER (-), PR (-), HER2 (0), (1+) or 2 (+) with FISH (-)); 3.No prior receipt of chemotherapy regimens for breast cancer; 4.Presence of at least one evaluable target lesion in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; 5.Availability of at least sufficient tissue samples for immunohistochemical testing and PD-1/PD-L1 status detection; 6.ECOG performance status score = 3.0 × 10^9/L; b. Neutrophil count (ANC) >= 1.5 × 10^9/L; c. Platelet count (PLT) >= 70 × 10^9/L; 9.Basically normal liver, kidney, and cardiac function tests (based on the normal reference ranges of the laboratory in each study center): a. Total bilirubin (TBIL) = 60 ml/min; 10.Normal cardiac function: a. Left ventricular ejection fraction (LVEF) >= 55%; b. QTcF (Fridericia correction) <= 470 ms; 11.Clear hormone receptor status; 12.Negative pregnancy test for female patients of childbearing potential, and agreement to use effective non-hormonal contraceptive methods during treatment and for at least 6 months after the last administration of the study drug; 13.Ability to understand the study procedures, voluntary participation in this study, and signature of the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pathologically confirmed HER2 positivity (immunohistochemistry [IHC] result of 2+ with FISH positivity, or IHC result of 3+); 2.Patients with known hypersensitivity to the active ingredients or other components of the study drugs; 3.Patients who received radiotherapy, chemotherapy, endocrine therapy within 2 weeks before enrollment, or are currently participating in any interventional drug clinical trial; 4.Pregnant or lactating women, and women of childbearing age who refuse to take effective contraceptive measures during the study; 5.Use of immunomodulatory drugs (including but not limited to thymopeptides, interleukin-2, interferons, etc.) within 14 days before the first administration of the study drug; 6.A history of other malignant tumors within the past 5 years, excluding cured carcinoma in situ of the cervix, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or other malignant tumors that do not affect enrollment as assessed by the investigator; 7.Patients with autoimmune diseases who require continuous treatment with immunomodulatory drugs; 8.Any other conditions deemed by the investigator to make the patient unsuitable for participation in this study. (1) Prolonged QT interval (QTc >450 msec in men or QTc >470 msec in women, QTc calculated using the Fridericia formula, determined based on three ECG readings taken more than 1 minute apart), complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias such as atrial fibrillation, atrial flutter, ventricular fibrillation, ventricular flutter (transient atrial fibrillation/flutter excluded); (2) Active autoimmune or inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, and active Hashimoto’s thyroiditis, excluding type I diabetes, hypothyroidism controlled by replacement therapy only, and skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis); (3) Ongoing long-term systemic corticosteroid therapy at >10 mg/day of prednisone equivalent or any form of immunosuppressive therapy before first dosing. Subjects requiring bronchodilators, inhaled or topical steroids, or local steroid injections may be included in this study; subjects with the following conditions prior to starting study treatment: a) poorly controlled diabetes (fasting glucose >10 mmol/L), b) severe diabetic complications such as diabetic nephropathy or peripheral neuropathy, c) HbA1c =8%, d) hypertension poorly controlled with two antihypertensive agents (systolic >150 mmHg or diastolic >100 mmHg), e) history of hypertensive crisis or hypertensive encephalopathy; (4) Current radiation pneumonitis = grade 2 according to RTOG/EORTC criteria; patients with current interstitial lung disease (ILD); (5) Coexisting pulmonary diseases resulting in severe impairment of respiratory function, including but not limited to: a) any underlying pulmonary disease (e.g., pulmonary embolism, severe asthma, severe COPD within 3 months prior to screening), b) restrictive lung disease, c) prior total pneumonectomy; (6) Unstable thrombotic events requiring treatment intervention within 6 months prior to screening, including deep vein thrombosis, arterial thrombosis, and pulmonary embolism (excluding infusion-related thrombosis); (7) Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastasis) and/or spinal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR( Pathological complete response); | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events;ORR?DCR;Overall Survival;Overall survival of patients with different clinical pathological characteristics including pCR, nonpCR, PD-L1 positve; | — |
Countries
China
Contacts
Public ContactYingliang Li
The first affiliated hostipal of nanchang university
Outcome results
None listed