NCT07638852招募中2 期
A Prospective, Two-arm, Multi-centre, Phase II Clinical Study of Radiotherapy Combined With Cisplatin/Carboplatin, Adebrelimab and Bevacizumab in the Treatment of Patients With Brain Metastasis From Triple-Negative Breast Cancer
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- 12-month CNS-PFS rate
研究概览
简要总结
This is an open-label, prospective, two-arm, multicenter phase II clinical trial. The aim is to explore the efficacy and safety of radiotherapy combined with cisplatin/carboplatin, adebrelimab, and bevacizumab in patients with triple-negative breast cancer and brain metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤70 years, gender not limited;
- •ECOG score 0-2;
- •Pathologically confirmed HR-negative/HER2-negative breast cancer patients with evidence of local recurrence or metastasis, unsuitable for curative surgical resection or radiotherapy; HR-negative is defined as ER-negative and PR-negative, with positive tumor cells accounting for <10% of all tumor cells;
- •Must not have previously used platinum-based drugs, or must have previously used platinum-based drugs (cisplatin or carboplatin and only one regimen) and meet the following definition of platinum sensitivity: no progression during at least 4 cycles of platinum-based therapy, and subsequent disease progression occurring more than 3 months after the last platinum-based therapy;
- •Expected survival ≥8 weeks;
- •MRI confirms brain metastasis, with at least one previously untreated intracranial brain parenchymal metastatic lesion with a longest diameter ≥1.0 cm;If the brain metastatic lesion has previously undergone radiotherapy, MRI is required to confirm progression after radiotherapy.
- •Provide sufficient fresh tissue specimens or tumor samples (primary lesion and/or metastatic lesions) ≥10 slides before treatment (preferably brain metastatic lesion specimens) for biomarker analysis.
- •9. Patients receiving mannitol, corticosteroids, or anticonvulsants prior to the first dose are eligible for enrollment if the doses of these concomitant medications have been stable for at least 1 week without escalation, and neurological symptoms have remained stable for ≥1 week.
- •10. Organ function levels must meet the following requirements:1) Complete blood count:• ANC ≥1.5×10⁹/L;• PLT ≥75×10⁹/L;• Hb ≥90 g/L (blood transfusion or drug treatment is allowed to ensure hemoglobin levels);2) Coagulation function: INR ≤1.5, APTT ≤1.5×ULN; PT not exceeding the upper limit of normal.3) Blood Biochemistry: • TBIL ≤ 1.5 × ULN;• ALT and AST ≤ 3 × ULN (liver metastases ≤ 5.0 × ULN);• Cr ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);3) Echocardiography: LVEF ≥ 50%;4) 12-lead ECG: Fridricia-corrected QT interval (QTcF) < 470 ms for women and < 450 ms for men;
- •Voluntary participation in this study, signing informed consent, good adherence, and willingness to cooperate with follow-up.
排除标准
- •Leptomeningeal metastases or cystic metastases confirmed by MRI or lumbar puncture;
- •Presence of third-space effusion (e.g., massive pleural effusion and ascites) that cannot be controlled by drainage or other methods;
- •Received whole-brain radiotherapy, chemotherapy, or surgery within 2 weeks prior to treatment with the investigational drug, or received endocrine therapy within one week prior to treatment;
- •Previous use of bevacizumab and PD-1/PD-L1 inhibitors, excluding the following: no disease progression during bevacizumab and PD-1/PD-L1 inhibitor use, investigators believe no drug resistance has been confirmed, and continued use would benefit the subject; short-term bevacizumab use to relieve cerebral edema;
- •Participation in other drug clinical trials within 2 weeks prior to enrollment;
- •Concurrent anti-tumor treatment for any other tumor;
- •History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;
- •History of any heart disease, including: (1) arrhythmia requiring medication or of clinical significance; (2) myocardial infarction; (3) heart failure; (4) any other heart disease deemed unsuitable for participation in this trial by the investigator;
- •A known history of allergy to any component of the medications in this regimen;
- •A history of immunodeficiency, including a positive HIV test, active hepatitis B/C, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- •A history of a defined neurological or psychiatric disorder, including epilepsy or dementia;
- •Pregnant or lactating women, women of childbearing age with a positive baseline pregnancy test, or patients who do not wish to use effective contraception throughout the trial;
- •In the investigator's judgment, a serious comorbidity that would jeopardize patient safety or affect the patient's ability to complete the study (including but not limited to severe hypertension uncontrolled by medication, severe diabetes, active infection, thyroid disease, etc.);
- •Any other circumstances deemed unsuitable for participation in this study by the investigator.
研究组 & 干预措施
Radiotherapy followed by systemic therapy group
Experimental
Patient who are eligible for inclusion will recieve radiotherapy first, followed by adebrelimab, bevacizumab and Cisplatin/Carplatin.
干预措施: Radiation Therapy (Radiation)
Radiotherapy followed by systemic therapy group
Experimental
Patient who are eligible for inclusion will recieve radiotherapy first, followed by adebrelimab, bevacizumab and Cisplatin/Carplatin.
干预措施: Adebelimab (Drug)
Systemic therapy followed by radiotherapy group
Experimental
Patient who are eligible for inclusion will recieve adebrelimab, bevacizumab and Cisplatin/Carplatin followed by radiotherapy.
干预措施: Radiation Therapy (Radiation)
Systemic therapy followed by radiotherapy group
Experimental
Patient who are eligible for inclusion will recieve adebrelimab, bevacizumab and Cisplatin/Carplatin followed by radiotherapy.
干预措施: Adebelimab (Drug)
Radiotherapy followed by systemic therapy group
Experimental
Patient who are eligible for inclusion will recieve radiotherapy first, followed by adebrelimab, bevacizumab and Cisplatin/Carplatin.
干预措施: Bevacizumab (Drug)
Radiotherapy followed by systemic therapy group
Experimental
Patient who are eligible for inclusion will recieve radiotherapy first, followed by adebrelimab, bevacizumab and Cisplatin/Carplatin.
干预措施: Cisplatin or carboplatin (Drug)
Systemic therapy followed by radiotherapy group
Experimental
Patient who are eligible for inclusion will recieve adebrelimab, bevacizumab and Cisplatin/Carplatin followed by radiotherapy.
干预措施: Cisplatin or carboplatin (Drug)
Systemic therapy followed by radiotherapy group
Experimental
Patient who are eligible for inclusion will recieve adebrelimab, bevacizumab and Cisplatin/Carplatin followed by radiotherapy.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
12-month CNS-PFS rate
时间窗: From randomization up to 12 months.
The 12-month CNS-PFS rate was used for intracranial efficacy assessment based on RANO-BM, and extracranial efficacy assessment based on RECIST 1.1.
次要结局
- CNS ORR(Up to 24 months(Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12))
- CNS CBR(Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12))
- ORR(Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12))
- CBR(Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12))
- DoR(From first documented response to progression or death, assessed up to 24 months)
- CNS PFS(From randomization to intracranial progression or death, assessed up to 24 months.)
- PFS(From randomization to progression or death, assessed up to 24 months.)
- OS(From randomization to death, assessed up to 24 months.)
- Adverse Events (AE)(From randomization through 30 days after the last dose of study treatment, assessed up to 24 months.)
- Hopkins Verbal Learning Test-Revised (HVLT-R)(At screening, 12, 24, 36, 48 weeks, 1.5 years, and 2 years after radiotherapy completion)
- Functional Assessment of Cancer Therapy-Brain (FACT-Br)(At screening, within 3 days before each cycle of treatment, and at end of treatment or safety follow-up, assessed up to 24 months)
- Mini-Mental State Examination (MMSE)(At screening, 12, 24, 36, 48 weeks, 1.5 years, and 2 years after radiotherapy completion)
- Animal Verbal Fluency Test(From enrollment to the end of treatment at 24 months，evaluations were conducted at screening, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 1.5 years, and 2 years after completion of radiotherapy.)
- Trail Making Test (TMT-A/TMT-B)(At screening, 12, 24, 36, 48 weeks, 1.5 years, and 2 years after radiotherapy completion)
- EORTC QLQ-C30(At screening, within 3 days before each cycle of treatment, and at end of treatment or safety follow-up, assessed up to 24 months)
- EORTC QLQ-BN20(At screening, within 3 days before each cycle of treatment, and at end of treatment or safety follow-up, assessed up to 24 months)
研究者
Jian Zhang,MD
Fudan University Shanghai Cancer Center
Fudan University
研究点 (1)
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