PDF(Pubmed)
Abstract：
UNASSIGNED: As one of the most important breakthroughs in cancer therapy, immune checkpoint inhibitors have greatly prolonged survival of patients with breast cancer. However, their application and efficacy are limited, especially for advanced HER2-negative breast cancer. It has been reported that epigenetic modulation of the histone deacetylase (HDAC) inhibitor chidamide, as well as immune microenvironment modulation of radiotherapy are potentially synergistic with immunotherapy. Thus, the combination of chidamide, radiotherapy and immunotherapy is expected to improve prognosis of patients with advanced HER2-negative breast cancer.
UNASSIGNED: This is a single-arm, open, prospective clinical trial investigating the efficacy and safety of the combination of HDAC inhibitor chidamide, anti-PD-1 antibody sintilimab, and the novel immuno-radiotherapy, which aims to enhance efficacy of immunotherapy, in subsequent lines of therapy of HER2-negative breast cancer. Our study will include 35 patients with advanced breast cancer that has failed endocrine therapy and first-line chemotherapy. Participants will receive 30 mg of chidamide twice a week, 200 mg of sintilimab once every 3 weeks, combined with immuno-radiotherapy. Radiotherapy will be centrally 8 Gy for at least one lesion, and at least 1 Gy for the other lesions. We will complete three fractions of radiotherapy in one cycle. The primary endpoint is progression-free survival, and secondary endpoints are objective response rate, disease control rate and safety. Moreover, biomarkers including cytokines and lymphocyte subgroups will be explored.
UNASSIGNED: As a single-arm clinical trial, the analysis of the influence of each single treatment is limited. Besides, our study is an open study, which involves neither randomization nor blinding. In spite of the abovementioned limitations, this prospective clinical trial will give an insight into subsequent lines of therapy of HER2-negative advanced breast cancer, prolong the survival or achieve long remission for these participants, and identify potential responders.
UNASSIGNED: This is a single-arm, open, prospective clinical trial investigating the efficacy and safety of the combination of HDAC inhibitor chidamide, anti-PD-1 antibody sintilimab, and the novel immuno-radiotherapy, which aims to enhance efficacy of immunotherapy, in subsequent lines of therapy of HER2-negative breast cancer. Our study will include 35 patients with advanced breast cancer that has failed endocrine therapy and first-line chemotherapy. Participants will receive 30 mg of chidamide twice a week, 200 mg of sintilimab once every 3 weeks, combined with immuno-radiotherapy. Radiotherapy will be centrally 8 Gy for at least one lesion, and at least 1 Gy for the other lesions. We will complete three fractions of radiotherapy in one cycle. The primary endpoint is progression-free survival, and secondary endpoints are objective response rate, disease control rate and safety. Moreover, biomarkers including cytokines and lymphocyte subgroups will be explored.
UNASSIGNED: As a single-arm clinical trial, the analysis of the influence of each single treatment is limited. Besides, our study is an open study, which involves neither randomization nor blinding. In spite of the abovementioned limitations, this prospective clinical trial will give an insight into subsequent lines of therapy of HER2-negative advanced breast cancer, prolong the survival or achieve long remission for these participants, and identify potential responders.
摘要：
■作为癌症治疗最重要的突破之一，免疫检查点抑制剂极大地延长了乳腺癌患者的生存期.然而,其应用和功效有限，尤其是晚期HER2阴性乳腺癌。据报道，组蛋白去乙酰化酶（HDAC）抑制剂西达胺的表观遗传调节，以及免疫微环境调节放疗可能与免疫治疗协同作用。因此，西达胺的组合，放疗和免疫治疗有望改善晚期HER2阴性乳腺癌患者的预后.
■这是单臂，打开,前瞻性临床试验，研究HDAC抑制剂西达本胺的疗效和安全性，抗PD-1抗体sintilimab，和新的免疫放射治疗，旨在提高免疫疗法的疗效，在随后的HER2阴性乳腺癌治疗中。我们的研究将包括35例内分泌治疗和一线化疗失败的晚期乳腺癌患者。参与者将每周两次接受30毫克西达胺，200毫克的sintilimab每3周一次，结合免疫放疗。至少一个病灶的放射治疗将集中在8Gy，其他病变至少1Gy.我们将在一个周期内完成三次放疗。主要终点是无进展生存期，次要终点是客观反应率，疾病控制率和安全性。此外，将探索包括细胞因子和淋巴细胞亚群在内的生物标志物。
■作为单臂临床试验，对每种单一处理的影响的分析是有限的。此外,我们的研究是一个开放的研究，既不涉及随机化也不涉及致盲。尽管存在上述限制，这项前瞻性临床试验将深入了解HER2阴性晚期乳腺癌的后续治疗方案，延长这些参与者的生存期或实现长期缓解，并确定潜在的反应者。
■这是单臂，打开,前瞻性临床试验，研究HDAC抑制剂西达本胺的疗效和安全性，抗PD-1抗体sintilimab，和新的免疫放射治疗，旨在提高免疫疗法的疗效，在随后的HER2阴性乳腺癌治疗中。我们的研究将包括35例内分泌治疗和一线化疗失败的晚期乳腺癌患者。参与者将每周两次接受30毫克西达胺，200毫克的sintilimab每3周一次，结合免疫放疗。至少一个病灶的放射治疗将集中在8Gy，其他病变至少1Gy.我们将在一个周期内完成三次放疗。主要终点是无进展生存期，次要终点是客观反应率，疾病控制率和安全性。此外，将探索包括细胞因子和淋巴细胞亚群在内的生物标志物。
■作为单臂临床试验，对每种单一处理的影响的分析是有限的。此外,我们的研究是一个开放的研究，既不涉及随机化也不涉及致盲。尽管存在上述限制，这项前瞻性临床试验将深入了解HER2阴性晚期乳腺癌的后续治疗方案，延长这些参与者的生存期或实现长期缓解，并确定潜在的反应者。
