NCT06849492尚未招募2 期
An Open, Multicenter Study on the Treatment of Recurrent and Metastatic Triple-negative Breast Cancer Guided by Cell Surface Protein Typing (HIM) in Triple-negative Breast Cancer
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
To explore the efficacy and safety of treatment for recurrent and metastatic advanced first-line triple-negative breast cancer guided by cell surface protein-based subtyping (HIM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 18 years old;
- •ECOG PS Score: 0~1;
- •Patients must have a life expectancy ≥ 3 months;
- •Histopathologically confirmed recurrent metastatic triple-negative invasive breast cancer (HER2-negative: IHC 0/1+ or IHC 2+ with negative ISH; ER-negative: IHC <1%, PR-negative: IHC <1%)；
- •At least one measurable lesion according to RECIST 1.1 criteria；
- •No prior systemic anti-tumor therapy during the recurrent or metastatic stage；
- •Sufficient tissue samples for HIM subtyping analysis (at least 15 unstained slides from the most recent metastatic lesion biopsy are required; primary lesion samples from treatment-naive patients are acceptable, and re-biopsy samples from such patients are also acceptable)；
- •Adequate organ function and marrow function;
- •Willing to join in this study, able to provide written informed consent, good compliance and willing to cooperate with follow-up.
排除标准
- •Has leptomeningeal metastasis or cystic metastatic lesions confirmed by MRI or lumbar puncture;
- •Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g.；
- •Received systemic anti-tumor therapy within 14 days prior to enrollment;
- •Imaging shows tumor invasion of major blood vessels, or the investigator judges that the tumor is highly likely to invade critical vessels during the study period, leading to life-threatening hemorrhage；
- •Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, serum calcium > 12 mg/dL, or albumin-corrected serum calcium > ULN); or symptomatic hypercalcemia requiring ongoing bisphosphonate therapy；
- •Prior treatment with immune checkpoint inhibitors other than PD-1/PD-L1 monoclonal antibodies (including but not limited to CTLA-4 antibodies, etc.), or anti-angiogenic agents (including monoclonal antibodies and TKIs)；
- •History of other malignancies within the past 5 years, having received any systemic anti-tumor therapy or local treatment (including surgery and radiotherapy) for malignancies, excluding cured in situ carcinomas, cervical carcinoma, basal cell carcinoma, squamous cell carcinoma, thyroid carcinoma, and other malignancies;
- •Major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures (tissue biopsy for diagnostic purposes and peripherally inserted central catheter placement are allowed);
- •Any known or suspected autoimmune disease, except for: hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy; or stable type I diabetes with controlled blood glucose;
- •Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, pulmonary fibrosis, acute pneumonia, etc.);
- •History of live or attenuated live vaccination within 28 days prior to the first study dose or planned live or attenuated live vaccination during the study period;
- •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 assay method) or co-infection with hepatitis B and C; autoimmune hepatitis;
- •Severe infections within 4 weeks prior to the first dose, including but not limited to bacteremia or severe pneumonia requiring hospitalization; or active infections requiring systemic antibiotic treatment with CTCAE ≥ grade 2 within 2 weeks prior to the first dose; or unexplained fever > 38.5°C during screening or prior to the first dose (fever due to tumor-related causes, as judged by the investigator, is allowed); evidence of active tuberculosis infection within 1 year prior to dosing;
- •History of or planned allogeneic bone marrow transplantation or solid organ transplantation;
- •Peripheral neuropathy ≥ grade 2;
- •Severe cardiac disease or conditions；
- •Subjects who have received systemic immunostimulant therapy (including but not limited to interferon or interleukin-2, including immunostimulants in clinical research stages) within 4 weeks prior to the first dose;
- •Subjects who have received systemic immunosuppressive therapy (including but not limited to glucocorticoids, azathioprine, methotrexate, thalidomide, anti-tumor factor drugs) within 2 weeks prior to the first dose. This exclusion does not apply to intranasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., no more than 10 mg/day prednisone or equivalent doses of other corticosteroids)；
- •Known allergy to the investigational drug or any of its excipients; or a history of severe allergic reactions to other monoclonal antibodies;
- •Female patients during the gestation or suckling period, of childbearing potential and pregnancy test-positive, or unwilling to use an effective method of contraception during the whole study;
- •A documented history of neurological or psychiatric disorders, including epilepsy or dementia, or a known history of substance abuse, alcoholism, or drug addiction.
- •Any other conditions not appropriate for study enrolment in the opinion of the investigator.
研究组 & 干预措施
Cohort C (M subtyping)
Experimental
干预措施: Nab-paclitaxel (Drug)
Cohort C (M subtyping)
Experimental
干预措施: Lenvatinib (Drug)
Cohort A (H subtyping)
Experimental
干预措施: Camrelizumab (Drug)
Cohort A (H subtyping)
Experimental
干预措施: Nab-paclitaxel (Drug)
Cohort B (I subtyping)
Experimental
干预措施: SKB264 (Drug)
Cohort C (M subtyping)
Experimental
干预措施: Camrelizumab (Drug)
结局指标
主要结局
ORR
时间窗: at the time point of every 12 weeks, up to one year
ORR is the percentage of evaluable patients with a confirmed investigator-assessed target lesion response of CR (complete response) or PR (partial response) per RECIST 1.1
次要结局
- CBR(up to 2 years)
- DoR(up to 2 years)
- PFS(up to 2 years)
- OS(up to 3 years)
- Safety(from time of informed consent provided to 3 months after the last dose of study therapy)
研究者
Hongxia Wang
Chief physician
Fudan University
研究点 (1)
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