[Translation] A multicenter, single-arm Phase II clinical study to evaluate the efficacy and safety of JK1201I in the treatment of triple-negative breast cancer patients with brain metastases

主要目的：评价JK1201I治疗合并有脑转移的三阴性乳腺癌患者的有效性。次要目的：评价JK1201I治疗合并有脑转移的三阴性乳腺癌患者的安全性；评价JK1201I治疗合并有脑转移的三阴性乳腺癌患者中给予JK1201I的群体药代动力学特征。

[Translation]

Primary purpose: To evaluate the effectiveness of JK1201I in the treatment of patients with triple-negative breast cancer with brain metastases. Secondary purpose: To evaluate the safety of JK1201I in the treatment of patients with triple-negative breast cancer with brain metastases; To evaluate the population pharmacokinetic characteristics of JK1201I in the treatment of patients with triple-negative breast cancer with brain metastases.

Start Date01 Nov 2024

Sponsor / Collaborator

JenKem Technology (Tianjin) Co., Ltd.

NCT06475443

/ Not yet recruitingPhase 2IIT

The Efficacy and Safety of Pyrotinib Plus Capecitabine in Human Epidermal Growth Factor Receptor 2-positive Breast Cancer Patients With Active Brain Metastases That Have Failed Antibody-drug Conjugate(ADC): a Prospective, Single Arm, Trial

To evaluate the efficacy and safety of pyrotinib plus capecitabine in HER2-positive breast cancer patients with active brain metastases that have failed ADCs

Start Date15 Jun 2024

Sponsor / Collaborator

Henan Cancer Hospital

NCT05781633

/ RecruitingNot ApplicableIIT

A Single-arm, Open-label， Phase Ⅱ Clinical Trial of Eutideron, Etoposide Combined With Bevacizumab for Breast Cancer Patients With Brain Metastases

This study was a single-arm, open-label, phase II study of breast cancer patients with brain metastases. Eligible patients received a regimen of eutidrone(30mg/m2/d,iv,d1-5,21d/cycle), etoposide(30mg/m2/d,iv,d1-3,21d/cycle), and bevacizumab (10mg/kg,d1,21d/cycle).At least 4 to 6 cycles were administered, and if patients had a response or stable disease, bevacizumab was used as maintenance therapy until disease progression or intolerable toxicity.

Start Date20 Jul 2022

Sponsor / Collaborator

Tianjin Cancer Institute

100 Clinical Results associated with Breast Carcinoma Metastatic in the Brain

100 Translational Medicine associated with Breast Carcinoma Metastatic in the Brain

0 Patents (Medical) associated with Breast Carcinoma Metastatic in the Brain

Literatures (Medical) associated with Breast Carcinoma Metastatic in the Brain

01 Mar 2025·Technology in Cancer Research & Treatment

Treatment Outcome of Brain Metastases from Breast Cancer Following Gamma Knife Radiosurgery: A Retrospective Study in Vietnam

Article

Author: Nguyen, Hoa Thi ; Nguyen, Tung Van ; Dang, Giang Tien ; Phan, Duong Thanh ; Le, Yen Thi ; Nguyen, Long Thanh ; Phung, Huyen Thi ; Nguyen, Quang Hong

BackgroundGamma Knife radiosurgery has proven to be highly effective for small brain lesions and those with a limited number of metastases. This study aimed to evaluate the treatment outcome of Gamma Knife radiosurgery in Vietnamese breast cancer patients with brain metastasis.MethodsThis retrospective descriptive study included 75 patients treated between January 2019 and December 2023. Eligible patients had 1 to 5 brain lesions ≤ 3 cm, a Karnofsky Performance Status (KPS) score of ≥ 60, and no prior whole-brain radiotherapy or brain tumor resection. Clinical characteristics were documented, and imaging responses were evaluated using RECIST criteria. Overall survival (OS), brain-specific progression-free survival (BSPFS), and overall response rates were analyzed using Kaplan-Meier survival curves and Cox regression.Results Seventy-five patients were included in the study, with a median follow-up time of 15.9 months. The median age was 53.0 years (range: 29-73 years), and 39 patients (52%) were HER2-positive. The median total tumor volume per patient was 3.78 cm 3 . A total of 152 brain tumors were identified, of which 131 (86.2%) were <2 cm in diameter, 36 patients (48.0%) had a single lesion. The intracranial tumor control rates were 96% at 3 months and 92.5% at 6 months. The median overall survival (OS) was 17.2 months (range: 13.7-20.7 months). Multivariate analysis revealed that the total volume of metastatic lesions ≤7.0 cm 3 , hormone receptor negativity, ≤ 3 lines of systemic treatment before brain metastasis and controlled extracranial metastases were correlated with both BSPFS and OS. ConclusionGamma Knife radiosurgery is an effective treatment for limited brain metastases, demonstrating a high rate of local control over brain lesions, which contributed to the promising survival outcome in Vietnamese breast cancer patients.

01 Aug 2024·Journal of Controlled Release

Auto-loaded TRAIL-exosomes derived from induced neural stem cells for brain cancer therapy

Article

Author: Satterlee, Andrew Benson ; Baldwin, Albert ; Valdivia, Alain ; Taylor, Hannah ; Corcoran, David L ; Herring, Laura E ; Kanchi, Krishna ; Dasari, Rajaneekar ; Steindler, Dennis A ; Hingtgen, Shawn ; Zhang, Xiaopei ; Buckley, Andrew ; Nguyen, Juliane ; Bonacquisti, Emily

Transdifferentiation (TD), a somatic cell reprogramming process that eliminates pluripotent intermediates, creates cells that are ideal for personalized anti-cancer therapy. Here, we provide the first evidence that extracellular vesicles (EVs) from TD-derived induced neural stem cells (Exo-iNSCs) are an efficacious treatment strategy for brain cancer. We found that genetically engineered iNSCs generated EVs loaded with the tumoricidal gene product TRAIL at nearly twice the rate of their parental fibroblasts, and TRAIL produced by iNSCs was naturally loaded into the lumen of EVs and arrayed across their outer membrane (Exo-iNSC-TRAIL). Uptake studies in ex vivo organotypic brain slice cultures showed that Exo-iNSC-TRAIL selectively accumulates within tumor foci, and co-culture assays demonstrated that Exo-iNSC-TRAIL killed metastatic and primary brain cancer cells more effectively than free TRAIL. In an orthotopic mouse model of brain cancer, Exo-iNSC-TRAIL reduced breast-to-brain tumor xenografts by approximately 3000-fold compared to treatment with free TRAIL, with all Exo-iNSC-TRAIL treated animals surviving through 90 days post-treatment. In additional in vivo testing against aggressive U87 and invasive GBM8 glioblastoma tumors, Exo-iNSC-TRAIL also induced a statistically significant increase in survival. These studies establish a novel, easily generated, stable, tumor-targeted EV to efficaciously treat multiple forms of brain cancer.

01 Feb 2022·Life SciencesQ3 · MEDICINE

Olvanil activates sensory nerve fibers, increases T cell response and decreases metastasis of breast carcinoma

Q3 · MEDICINE

Article

Author: Akman, Muhlis ; Tanrıöver, Gamze ; Aliyev, Elnur ; Korcum, Aylin F ; Erin, Nuray

BACKGROUNDInactivation of sensory neurons expressing transient receptor potential vanilloid 1 (TRPV1) enhances breast cancer metastasis. Sensory neurons have profound effects on immune response to a wide range of diseases including cancer. Hence, activation of sensory nerves using feasible approaches such as specific TRPV1 agonists may inhibit breast cancer metastasis through neuroimmune pathways. TRPV1 agonists are considered for the treatment of pain and inflammatory diseases.METHODSWe here first determined the effects of four different TRPV1 agonists on proliferation of three different metastatic breast carcinoma cells since TRPV1 is also expressed in cancer cells. Based on the results obtained under in-vitro conditions, brain metastatic breast carcinoma cells (4TBM) implanted orthotopically into the mammary-pad of Balb-c mice followed by olvanil treatment (i.p.). Changes in tumor growth, metastasis and immune response to cancer cells were determined.RESULTSOlvanil dose-dependently activated sensory nerve fibers and markedly suppressed lung and liver metastasis without altering the growth of primary tumors. Olvanil (5 mg/kg) systemically increased T cell count, enhanced intra-tumoral recruitment of CD8+ T cells and increased IFN-γ response to irradiated cancer cells and Con-A. Anti-inflammatory changes such as increased IL-10 and decrease IL-6 as well as S100A8+ cells were observed following olvanil treatment.CONCLUSIONSOur results show that anti-metastatic effects of olvanil is mainly due to activation of neuro-immune pathways since olvanil dose used here is not high enough to directly activate immune cells. Furthermore, olvanil effectively depletes sensory neuropeptides; hence, olvanil is a good non-pungent alternative to capsaicin.

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