背景:乳腺癌的化疗是有效的,但可以产生明显的毒性并导致肿瘤耐药。使用标准化植物提取物的联合治疗可以是改善反应并允许抗肿瘤免疫反应的有效激活的替代方案,这有利于短期和长期的恢复。刺槐P2Et提取物在乳腺癌细胞和动物模型中具有抗肿瘤活性,改善肿瘤微环境,并诱导针对肿瘤的特异性免疫反应的激活,并且与蒽环类药物一起使用时具有协同作用,这使得它成为患者评估的一个很好的候选人。
方法:在单个中心进行,这个第二阶段的研究是随机的,双盲,安慰剂对照试验旨在评估P2Et提取物在诊断为II期和III期乳腺癌患者中的安全性和有效性,谁有资格接受新辅助治疗。该研究旨在确定I期试验中先前确定的最佳生物剂量的安全性,同时研究各种疗效结果。这些结果包括生活质量的改善,免疫调节,代谢概况,微生物组,以及肿瘤减少等临床指标,无病生存,和病理反应,在治疗方案的不同阶段进行评估。
结论:假设在乳腺癌患者中使用P2Et提取物治疗可以提高总体幸福感,积极影响他们的生活质量,同时也引发抗肿瘤免疫反应和增强免疫浸润。这些联合效应有可能有助于改善接受植物药和新辅助化疗治疗的患者的长期生存结果。
背景:该试验在美国国家医学图书馆注册,标识符为NCT05007444。首次注册于8月16日,2021年。最后更新时间:8月9日,2022年。
BACKGROUND: Chemotherapy in breast cancer is effective but can generate significant toxicity and lead to tumor resistance. Joint treatment with standardized plant extracts can be an alternative to improve the response and allow an effective activation of the antitumor immune response that favors recovery in the short and long term. The P2Et extract of
Caesalpinia spinosa presents antitumor activity in cells and animal models of breast cancer, improves the tumor microenvironment, and induces activation of the specific immune response against the tumor and is synergistic when used together with anthracyclines, which makes it a good candidate for evaluation in patients.
METHODS: Conducted at a single center, this phase II
study is a randomized, double-blind, placebo-controlled
trial aimed at assessing the safety and efficacy of P2Et extract in patients diagnosed with stage II and III breast cancer, who are eligible for neoadjuvant treatment. The
study aims to determine the safety profile at the previously established optimal biological dose from phase I
trial while investigating various efficacy outcomes. These outcomes include improvements in quality of life, immunomodulation, metabolic profile, microbiome, as well as clinical indicators such as tumor reduction, disease-free survival, and pathological response, assessed at different stages of the treatment regimen.
CONCLUSIONS: Treatment with the P2Et extract in breast cancer patients is hypothesized to enhance overall well-being, positively influencing their quality of life, while also triggering an antitumor immune response and enhancing immune infiltration. These combined effects have the potential to contribute to improved long-term survival outcomes for patients receiving the phytomedicine alongside neoadjuvant chemotherapy treatment.
BACKGROUND: This trial was registered in the US National Library of Medicine with identifier NCT05007444. First Registered August 16th, 2021. Last Updated: August 9th, 2022.