Breast cancer
Conditions
Interventions
Experimental Group:TCb + Toripalimab + Radiotherapy
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) The subject or their legal representative voluntarily signs the written informed consent form. (2) Female patients aged 18 to 75 years (inclusive). (3) Diagnosed with triple-negative breast cancer by cytological or histological examination. (4) Having at least one measurable target lesion according to the RECIST 1.1 criteria. (5) Patients with newly diagnosed stage IIB or III breast cancer, who are evaluated as stable disease (SD) or progressive disease (PD) per RECIST 1.1 criteria on the day before the planned third cycle of treatment after receiving 2 cycles of neoadjuvant chemotherapy with the EC regimen. (6) Planned to undergo definitive surgical resection for breast cancer. (7) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. (8) With adequate organ and bone marrow function. (9) For premenopausal females or those without surgical sterilization: agree to abstain from sexual intercourse or adopt effective contraceptive measures during the treatment period and for at least 7 months after the last dose of study treatment. Women of childbearing potential who have undergone surgical sterilization (including hysterectomy, bilateral oophorectomy or total hysterectomy) or are postmenopausal (defined as absence of menses for at least 12 consecutive months without medical cause) will be considered to have no potential for pregnancy.
Exclusion criteria
Exclusion criteria: (1) Patients with bilateral breast cancer, multicentric breast cancer, inflammatory breast cancer, or breast cancer with distant metastasis. (2) Patients who have previously received any antitumor therapy other than neoadjuvant chemotherapy, including endocrine therapy, immunotherapy, targeted therapy and radiotherapy; or patients who have undergone breast surgery (excluding diagnostic biopsy for primary breast cancer). (3) History of hypertensive crisis or hypertensive encephalopathy; uncontrolled hypertension despite medication (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg). (4) History of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollment, such as pulmonary embolism, cerebral infarction, transient ischemic attack, myocardial infarction, etc. Patients with catheter-related mural thrombosis that requires no treatment are eligible for enrollment. (5) Patients with significant vascular diseases (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis), unstable angina pectoris, cardiac insufficiency classified as New York Heart Association (NYHA) Class ? or above, or severe arrhythmia uncontrolled by medications. (6) Patients with a history of major surgery or severe trauma within 4 weeks prior to enrollment; subjects with any evidence or history of bleeding diathesis regardless of severity; subjects with any bleeding event >= CTCAE Grade 3 within 4 weeks before the first study drug administration; subjects with unhealed wounds, fractures, active gastroduodenal ulcer, ulcerative colitis or other gastrointestinal diseases, unresected tumors with active bleeding, or any other conditions judged by the investigator to be likely to cause gastrointestinal bleeding or perforation. (7) Patients with any active autoimmune disease, or a history of autoimmune disease with expected recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, hypophysitis, vasculitis, etc.). The following conditions are not excluded: Type 1 diabetes well-controlled with fixed-dose insulin; hypothyroidism managed with hormone replacement therapy or requiring no treatment; skin diseases without the need for systemic therapy (e.g., eczema, rash involving less than 10% of body surface area, psoriasis without ocular manifestations). (8) Patients with a confirmed clinical diagnosis of interstitial lung disease, pulmonary fibrosis or drug-induced pneumonitis, or evidence of active pneumonia requiring treatment detected on chest CT within the past 3 months; patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis therapy within 1 year prior to screening. (9) Uncontrolled pleural effusion, pericardial effusion or ascites that requires repeated drainage. (10) Patients with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis B (HBV DNA >= 1000 IU/mL); hepatitis C infection (positive anti-HCV antibody with HCV-RNA level above the lower limit of assay detection); or co-infection with hepatitis B and hepatitis C. (11) Pregnant or lactating female subjects; women of childbearing potential or male subjects who are unwilling or unable to use acceptable contraceptive methods throughout the study treatment period and for 7 months after the last dose of investigational product. Women of childbearing po
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Event-Free Survival; | — |
Countries
China
Contacts
Public ContactXiaohua Zeng
Chongqing University Cancer Hospital
Outcome results
None listed