Inoperable locally advanced or metastatic triple-negative breast cancer
Conditions
Interventions
Experimental group:Aribulin combined with Ivonescimab
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old (including boundary value), gender is not limited; 2. ECOG physical fitness score (PS) 0-1 points; 3. Subjects need to provide a two-year memory file and/or fresh tumor tissue sample, histologically or cytologically confirmed TNBC (ER, PR and HER2 are all negative) by the central laboratory: (1) Negative ER and PR are defined as: ER less than 1% and PR less than 1% detected by IHC; (2) HER2 negativity is defined as: IHC test 0 (negative/-) or 1, if it is 2, ISH or FISH test must be performed and the result is negative; (3) For patients with ER/PR expression >=1% and =12 months; The interval between the end time of adjuvant therapy (date of last dose) of other drugs such as capecitabine (such as PD-1/PD-L1 inhibitors) and the first documented locally advanced, recurrence or metastasis >=6 months; (2) Those who received surgical treatment alone (in the absence of neoadjuvant/adjuvant therapy before/after surgery), the time interval between the date of surgery and the first recorded locally advanced, recurrence or metastasis was >=6 months; 5. At least one measurable (non-brain metastasis) tumor lesion according to the Evaluation Criteria for Efficacy in Solid Tumors (RECIST 1.1) criteria. CT or MR scan, the longest diameter of non-lymph node lesions is at least >=10mm, and the short diameter of lymph node lesions is >=15mm (tumor lesions that have received radiotherapy or other locoregional therapy have clearly documented disease progression after the end of treatment as measurable lesions; If the selected target lesion undergoes pathological biopsy during the screening period, an interval of at least 2 weeks from the time of the first dose is required); 6. Expected survival time>=12 weeks; 7. Have adequate organ and bone marrow function: Laboratory tests meet the following conditions within 1 week prior to enrollment (based on normal values in the laboratory department of each study center): (1) Blood routine: WBC>= 3.0×109/L, ANC>=1.5×10^9/L; PLT >= 90 ×10^9/L; HGB>= 9.0g/dL; (2) Liver function: TBiL=30g/L; For subjects with liver metastasis or bone metastasis, ALP<=5×ULN; (3) Renal function: Scr<=1.5×ULN; or creatinine clearance (Ccr) calculated according to the Cockcroft-Gault formula
Exclusion criteria
Exclusion criteria: 1. Thyroid cancer, cervical carcinoma in situ, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin that have been cured after treatment within 5 years before enrollment can be enrolled; 2. Participation in clinical trials or clinical studies of other investigational drugs or investigational devices within 28 days before the first dose; or received anti-tumor therapy within 4 weeks or within 5 half-lives of the drug (whichever is shorter) before the first dose, including but not limited to chemotherapy, radiotherapy (palliative radiotherapy completed at least 2 weeks before study drug treatment is allowed), targeted therapy, immunotherapy, or endocrine therapy; Received proprietary Chinese (herbal) drugs or non-specific immunomodulatory therapy with anti-tumor indications (such as interleukin, interferon, thymus peptide, tumor necrosis factor, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks before the first dose; 3. Previous treatment adverse events (alopecia, grade 10mg/day prednisone or equivalent dose) or other immunosuppressive drugs within 14 days before the first dose. If there is no active autoimmune disease, inhaled, ophthalmological, or topical glucocorticoids or other glucocorticoids at a dose of <=10mg/day prednisone or equivalent dose are allowed (glucocorticoid therapy used to prevent contrast allergy in imaging examinations such as CT is allowed); 7. Known uncontrollable or symptomatic active CNS metastases. However, for subjects with asymptomatic brain metastases, they can be enrolled if they meet the following conditions: (1) Imaging and neurological examinations are stable for more than 4 weeks after receiving relevant treatment; (2) If there is no imaging evaluation, the neurological examination is stable for more than 4 weeks under glucocorticoid therapy, and the prednisone dose used before the first dose of study drug is =10mg/day or equivalent dose of other hormones; 8. Presence of brainstem, meningeal metastasis, spinal cord metastasis or compression; 9. Tumor invasion or compression of surrounding important organs (such as aorta, heart and pericardium, superior vena cava, trachea, esophagus, etc.) or there is a risk of esophagotracheal fistula or esophagopleural fistula; Tumor mediastina
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival;Duration of Response;Safety; | — |
Countries
China
Contacts
Public ContactLu Haiqi
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed