First-line advanced triple-negative breast cancer
Conditions
Interventions
Lenvatinib
Cohort A (H subtyping):Camrelizumab
Cohort B (I subtyping):Sacituzumab Tirumotecan (SKB-264)
Cohort C (M subtyping):Camrelizumab
Nab-paclitaxel
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Breast cancer patients aged >=18 years; 2. Recurrent histopathologically confirmed metastatic triple-negative invasive breast cancer as defined by the latest ASCO/CAP guidelines, based on recent and prior pathological findings, while meeting the following criteria: HER2 negative: IHC 0/1 or IHC2 but ISH negative; ER negative: IHC=1.5×10^9/L (no use of hematopoietic stimulating factor drugs within 14 days prior to the first dose of the study); Platelet count (PLT) >=100×10^9/L (no blood transfusion within 14 days prior to the first dose of the study); Hemoglobin (Hb) >=90 g/L; Blood biochemistry total bilirubin (TBIL) = 50% and 12-lead ECG: QTcF < 480ms 10. Females of childbearing potential must have a serum pregnancy test within 7 days prior to enrollment with a negative result and be willing to use one medically recognized highly effective contraceptive measure for the duration of the study and for 3 months after the last dose of study drug; 11. Subjects voluntarily join this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Tumor-related symptoms and treatment 1) Active or symptomatic brain metastases: metastases in the midbrain, pons, medulla, or spinal cord; meningeal metastases; Neurologic symptoms such as increased intracranial pressure, neurologic abnormalities; Surgical treatment within 28 days of enrollment, whole brain radiotherapy within 14 days, or stereotactic radiosurgery within 7 days; Patients with only supratentorial and/or cerebellar metastases, who have undergone local therapy (surgery/radiotherapy for all known lesions), who have been clinically stable for at least 2 weeks after completion of treatment, who do not show disease progression or bleeding on imaging, and who do not require hormonal therapy within 14 days of the first dose or who receive = 10mg/day of prednisone or equivalent dose hormonal therapy can participate in the study; 2) Uncontrollable moderate to large pleural effusion, ascites effusion or pericardial effusion requiring repeated drainage; 3) Systemic anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 14 days prior to enrollment; 4) Those whose imaging examination shows that the tumor invades the large blood vessels or the investigator judges that the tumor is very likely to invade the important blood vessels during the follow-up study and cause fatal hemorrhage; 5) Subjects with uncontrolled or symptomatic hypercalcemia (> 1.5mmol/L ionized calcium concentration or > 12mg/dL serum calcium concentration or serum calcium (albumin-corrected) concentration >ULN); or symptomatic hypercalcemia requiring continued bisphosphonate therapy; 6) Previous treatment with other immune checkpoint inhibitors (including but not limited to CTLA-4 antibodies, etc.) or anti-angiogenic drugs (including monoclonal antibodies and TKIs) other than PD-1/PD-L1 monoclonal antibodies; 2. Comorbid disease/medical history 1) Other malignant tumors within the past 5 years, and have received any systemic anti-tumor therapy or local therapy (including surgery and radiotherapy) for malignant tumors, excluding cured malignant tumors such as carcinoma in situ, cervical cancer, basal cell carcinoma or squamous cell carcinoma, thyroid cancer, etc.; 2) Significant surgical procedures unrelated to breast cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures (tissue biopsy and central venous catheter placement via peripheral venipuncture required for diagnosis are permitted); 3) Subjects with any known or suspected autoimmune disease, except: hypothyroidism due to autoimmune thyroiditis requiring hormone replacement therapy treatment only; Subjects with stable type I diabetes mellitus with glycemic control; 4) Presence of interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as: diabetes, pulmonary fibrosis and acute pneumonia, etc.); 5) History of live vaccine or live attenuated vaccine within 28 days prior to the first study administration or expected live vaccine or live attenuated vaccine during the study; 6) Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); Active hepatitis (hepatitis B, defined as HBV-DNA >= 30 copies/ml; Hepatitis C, defined as HCV-RNA above the lower limit of detection of the analytical method) or co-infection with hepatitis B and C; autoimmune hepatitis; 7) Severe infection within
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, PFS;Clinical Benefit Rate (CBR);Overall Survival, OS; | — |
Countries
China
Contacts
Public ContactHongxia Wang
Fudan University Shanghai Cancer Center
Outcome results
None listed