A Phase II Clinical Study of Sacituzumab Govitecan Combined With Head Radiotherapy for the Treatment of Brain Metastases From Her2-negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 43
- 主要终点
- 1-year CNS progression-free survival (NPFS)
研究概览
简要总结
The incidence of brain metastasis of Her2-negative breast cancer is high, which seriously affects the prognosis of patients.The treatment of brain metastasis of Her2-negative breast cancer is still tricky. The local efficacy of head radiotherapy for breast cancer brain metastases is remarkable, and systemic tumor progression in patients with brain metastases is the main reason for treatment failure. Sacituzumab Govitecan is the only Trop-2 antibody-coupled drug (ADC) approved for the treatment of unresectable locally advanced or metastatic Her2-negative breast cancer. However, the objective remission rate of Sacituzumab Govitecan for intracranial metastatic lesions has not been satisfactory. This study is an open, uncontrolled phase II clinical study to observe the efficacy and safety of Sacituzumab Govitecan combined with intracranial radiotherapy in the treatment of patients with brain metastases from Her2-negative breast cancer, in order to find a more effective treatment method.
详细描述
This study is a single-arm open phase II clinical trial. It aims to observe the effectiveness and safety of Sacituzumab Govitecan combined with head radiotherapy in the treatment of Her2-negative breast cancer brain metastases, and to search for a more effective treatment option for Her2-negative breast cancer brain metastases. Patients were treated with Sacituzumab Govitecan 10mg/kg every 21 days as a treatment cycle, which was infused intravenously on day 1 and day 8, and the treatment was continued until the disease progressed or unacceptable toxicity occurred. Radiotherapy was administered after the second infusion of Sacituzumab Govitecan, on day 9 after the start of this regimen. The radiotherapy regimen was: brain metastases at a dose of 60 Gy/20 doses. For lesions located adjacent to the brainstem and optic nerve, 54 Gy/20 doses were given. For patients with ≥5 lesions, whole-brain radiotherapy at 40 Gy/20 doses was synchronized with radiotherapy to localized brain metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a definitive pathologic diagnosis of breast cancer with subtype Her2- (including IHC 0, IHC 1+ or IHC 2+ and ISH negative);
- •Have a measurable intracranial lesion;
- •Age ≥ 18 years;
排除标准
- •Patients with cerebrospinal membrane metastases;
- •Patients with acute/subacute hemorrhagic metastasis;
- •Inadequate organ function: 1) Blood tests: ANC ≤ 1.5 x 10^9/L, PLT ≤ 90 x 10^9/L, Hb ≤ 90g/L; 2) Blood biochemistry tests: TBIL ≥ 1.5 times the upper limit of normal; 3) ALT and AST ≥ 2.5 times the upper limit of normal;
- •Presence of serious and/or uncontrolled comorbidities that may affect participation: 1) allergy to study medications or adjuvant materials; 2) history of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency diseases; 3) serious concomitant illnesses;
- •Pregnant and lactating female patients; female patients of childbearing age who are unwilling to use effective contraception during the trial period;
- •Patients who are unable to complete enhanced contrast MRI;
- •Patients who have been treated with Sacituzumab Govitecan and are resistant to the drug;
- •Any other condition that, in the opinion of the investigator, makes the patient ineligible for study participation.
研究组 & 干预措施
Group
Patients were treated with Sacituzumab Govitecan 10 mg/kg in 21-day treatment cycles with intravenous infusions on days 1 and 8 and continued until disease progression or unacceptable toxicity. Radiotherapy was administered after the second infusion of Sacituzumab Govitecan, on day 9 after the start of this regimen. The radiotherapy regimen was: brain metastases at a dose of 60 Gy/20 doses. For lesions located adjacent to the brainstem and optic nerve, 54 Gy/20 doses were given. For patients with ≥5 lesions, whole-brain radiotherapy at 40 Gy/20 doses was synchronized with radiotherapy to localized brain metastases.
干预措施: Sacituzumab Govitecan (Drug)
Group
Patients were treated with Sacituzumab Govitecan 10 mg/kg in 21-day treatment cycles with intravenous infusions on days 1 and 8 and continued until disease progression or unacceptable toxicity. Radiotherapy was administered after the second infusion of Sacituzumab Govitecan, on day 9 after the start of this regimen. The radiotherapy regimen was: brain metastases at a dose of 60 Gy/20 doses. For lesions located adjacent to the brainstem and optic nerve, 54 Gy/20 doses were given. For patients with ≥5 lesions, whole-brain radiotherapy at 40 Gy/20 doses was synchronized with radiotherapy to localized brain metastases.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
1-year CNS progression-free survival (NPFS)
时间窗: From the time patients receive this treatment until the next 1 year
Proportion of patients free of CNS progression at 1 year from the time the patient receives this treatment. Neurological progression was assessed according to the Response Assessment of Neuro-Oncology Brain Metastases (RANO-BM) criteria.
次要结局
- Rate of new intracranial lesions(Assessed 2 months after the end of treatment or at the time of patient's death)
- Incidence of Treatment-Related Adverse Events(Assessments were performed 2 months after the end of treatment or at the time of the patient's death)
- Overall survival(Assessments were performed at least 7 months after diagnosis of brain metastases or before death)
- Intracranial objective remission rate (IORR)(Assessed at 2 months after the end of treatment or at the time of patient death)
- Overall progression-free survival (PFS)(All patients received at least 6 months of follow-up, and NPFS was assessed from the start of treatment to the date of the first documented progression of an extracranial lesion or the date of death from any cause, whichever came first.)
研究者
Zhenyu Pan
Professor
Guangzhou Medical University