TNBC
Conditions
Interventions
Late TNBC treatment group and early TNBC neoadjuvant treatment group:None
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Voluntary participation with signed informed consent form; 2.Pathologically confirmed triple-negative breast cancer (TNBC): Cohort A (patients with unresectable locally advanced or metastatic TNBC, diagnosis from either primary or metastatic lesions acceptable), Cohort B (patients with early-stage TNBC in the neoadjuvant setting); 3.<=1 prior line of chemotherapy for locally advanced or metastatic breast cancer; 4.Have initiated treatment with chemotherapy combined with toripalimab within 2 cycles; 5.Will receive treatment with chemotherapy combined with toripalimab; 6.Have traceable medical records during treatment.
Exclusion criteria
Exclusion criteria: 1. Imaging showing tumor invasion of major blood vessels, or investigator determination that tumor is highly likely to invade critical vessels causing fatal hemorrhage during the study; 2.Uncontrolled or symptomatic hypercalcemia (>1.5 mmol/L ionized calcium or >12 mg/dL serum calcium or albumin-corrected serum calcium > ULN); or symptomatic hypercalcemia requiring continued bisphosphonate therapy; 3. Comorbidities/Medical history: (1). Other malignancies within 5 years prior, having received any systemic antitumor therapy or local treatment (including surgery and radiotherapy) for malignancy, excluding cured carcinoma in situ, cervical cancer, basal cell carcinoma, squamous cell carcinoma, thyroid cancer, etc.; (2). Major surgery unrelated to breast cancer within 4 weeks before enrollment, or patient not fully recovered from such surgery (biopsies for diagnostic purposes and peripherally inserted central catheter placement are permitted); (3). Any known or suspected autoimmune disease, except: hypothyroidism from autoimmune thyroiditis requiring only hormone replacement therapy; stable Type I diabetes with controlled blood glucose;(4). Presence of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic disease (e.g., diabetes, pulmonary fibrosis, acute pneumonia, etc.); (5). History of live or attenuated vaccine within 28 days before first study drug administration, or anticipated vaccination during the study; (6). HIV infection or known AIDS; active hepatitis (HBV defined as HBV-DNA >= 30 copies/ml; HCV defined as HCV-RNA above assay detection limit) or HBV/HCV coinfection; autoimmune hepatitis;(7). Severe infection within 4 weeks before first dose, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; or active infection requiring systemic antibiotics with CTCAE >= Grade 2 within 2 weeks before first dose, or unexplained fever >38.5°C during screening/before first dose (tumor-related fever per investigator judgment is allowed); evidence of active tuberculosis within 1 year before dosing; (8). History of or planned allogeneic bone marrow or solid organ transplantation; (9).Serious cardiac disease or discomfort, including but not limited to: • Confirmed history of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia) or higher-grade atrioventricular block (i.e., Mobitz II second-degree or third-degree AV block) • Angina requiring anti-anginal medication • Clinically significant valvular heart disease • ECG showing transmural myocardial infarction • Poorly controlled hypertension (systolic BP >180 mmHg and/or diastolic BP >100 mmHg); 4.Study treatment-related: (1). Received systemic immunosuppressive therapy (including but not limited to corticosteroids, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents) within 2 weeks before first dose. Excludes intranasal/inhaled corticosteroids or physiological-dose systemic steroids (i.e., <=10 mg/day prednisone or equivalent); (2). Known hypersensitivity to study drug or any excipients, or history of severe allergic reaction to other monoclonal antibodies; 5.Pregnant or lactating women; women of childbearing potential with positive baseline pregnancy test; or women of reproductive age unwilling to use effective contraception throughout the trial and for 6 m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Overall survival;Security;PCR and EFS (early neoadjuvant patients) and safety; | — |
Countries
China
Contacts
Public ContactXiaojia Wang
Zhejiang Cancer Hospital
Outcome results
None listed