Sacituzumab Govitecan Combined With Head Radiotherapy for Her2-negative Breast Cancer Brain Metastases
NCT Number: NCT06462079
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Brain Metastasis
Interventions: DRUG: Sacituzumab Govitecan|RADIATION: Radiotherapy
Sponsor: Guangzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 43
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2027-07-15

Summary:
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.

Primary Outcome Measures: 1-year CNS progression-free survival (NPFS), 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., From the time patients receive this treatment until the next 1 year
Secondary Outcome Measures: Intracranial objective remission rate (IORR), The proportion of patients whose brain metastases shrink in volume to achieve complete remission/partial remission from the time the patient receives this treatment. Complete remission/partial remission is assessed according to the Response Assessment of Neuro-Oncology Brain Metastases (RANO-BM) criteria, Assessed at 2 months after the end of treatment or at the time of patient death|Rate of new intracranial lesions, The proportion of patients presenting with new brain metastases from the time the patient received treatment. New brain metastases are assessed according to the Response Assessment of Neuro-Oncology Brain Metastases (RANO-BM) criteria., Assessed 2 months after the end of treatment or at the time of patient's death|Overall progression-free survival (PFS), The time from the time the patient receives this treatment to the time of disease progression or death. Assessment of extracranial lesions follows the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)., 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.|Overall survival, Survival time was recorded from the date of patient enrollment. All patients were followed until death or the end of the study., Assessments were performed at least 7 months after diagnosis of brain metastases or before death|Incidence of Treatment-Related Adverse Events, The incidence of treatment-related adverse events was measured to determine tolerability and safety. Adverse events (AEs) were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4.03).Grade 3-5 events were defined as moderate and severe adverse events., Assessments were performed 2 months after the end of treatment or at the time of the patient's death