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Carson III, MD 1,3\u003Cbr>Abstract\u003Cbr>Objectives: CpG ODN is a Toll-like receptor 9 agonist with immunotherapeutic potential for many cancer types, including aggressive breast cancers. There is strong interest in utilizing CpG ODN as an adjuvant to improve clinical efficacy of current treatments and immunogenicity of breast cancers not traditionally responsive to active immunotherapy, such as those that are human epidermal growth factor receptor 2 (HER2)-positive. This study aimed to study the efficacy and safety of combination CpG ODN plus anti-HER2 antibody trastuzumab treatment in patients with advanced/metastatic breast cancer.\u003Cbr>Methods: This single-arm, open-label phase II clinical trial treated patients (n = 6) with advanced/metastatic HER2-positive breast cancer with weekly subcutaneous CpG ODN and trastuzumab. Patients may have received any number of prior therapies to be enrolled (most enrolled at median 1 prior line of chemotherapy). Peripheral blood was collected at baseline and weeks 2, 6, 12, and 18 for immune analyses. Six patients were enrolled and 50% achieved stable disease (SD) response.\u003Cbr>Results: Median PFS was 8.3 months. Three of the six patients enrolled opted to stop treatment due to tolerability issues. Multiplex assay for cytokine measurements revealed significantly higher VEGF-D levels at week 2 compared to baseline. Peripheral blood mononuclear cells analyzed by flow cytometry showed a significant increase in monocytic MDSC between weeks 6 and 12. Patients with progressive disease tended to have higher levels of week 6 monocytic MDSC and PD-1+ T cells than patients with SD. NK cell populations did not significantly change throughout treatment.\u003Cbr>Conclusions: CpG ODN and trastuzumab treatment of metastatic HER2 + breast cancer was safe but was not tolerable for all patients. This combination did induce potentially predictive immune profile changes in treated patients with metastatic HER2 + breast cancer, the significance of which needs to be further explored. |  |\n| 1 Pelotonia Institute for Immuno-Oncology, The James Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA 2Department of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, OH, USA\u003Cbr>3Department of Surgery, The Ohio State University, Columbus, OH, USA 4Miami Valley Hospital, Dayton, OH, USA\u003Cbr>5Center for Biostatistics, The Ohio State University, Columbus, OH, USA 6Columbus Oncology Associates, Columbus, OH, USA\u003Cbr>7Yale School of Medicine, New Haven, CN, USA 8St. Rita’s Cancer Center, Lima, OH, USA\u003Cbr>Corresponding Author:\u003Cbr>William E. Carson, III, MD Department of Surgery The Ohio State University N924 Doan Hall 410 W. 10th Avenue Columbus, OH 43210, USA. Email: wi[lliam.carson@osumc.edu](lliam.carson@osumc.edu) |  |\n\nCreative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons  \nAttribution-NonCommercial 4.0 License ([https://creativecommons.org/licenses/by-nc/4.0/](https://creativecommons.org/licenses/by-nc/4.0/)) which permits non-commercial use,  \nreproduction and distribution of the work wit","cbCaitvlNc4vaa2M","https://ap.wps.com/l/cbCaitvlNc4vaa2M","pdf",1081296,15,"English","# Abstract\n## Objectives\n## Methods\n## Results\n## Conclusions\n# Plain Language Summary\n## Why was the study done?\n## What did the researchers do?\n## What did the researchers find?\n## What do the findings mean?","[{\"question\":\"What was the purpose of this study?\",\"answer\":\"To assess the efficacy and safety of combining subcutaneous CpG ODN with trastuzumab in patients with advanced/metastatic HER2+ breast cancer and to evaluate immune effects.\"},{\"question\":\"How was the trial conducted and who participated?\",\"answer\":\"This was a single-arm, open-label phase II trial with six patients treated weekly with subcutaneous CpG ODN plus trastuzumab.\"},{\"question\":\"What were the key findings for disease control, safety, and immune markers?\",\"answer\":\"Fifty percent achieved stable disease and median PFS was 8.3 months. Treatment was not tolerable for all patients, with three stopping due to tolerability issues. Immune analyses showed higher VEGF-D at week 2 and increased monocytic MDSC (and PD-1+ T cells in progressive disease), while NK cells did not significantly change.\"}]","An Open-Label Study of Subcutaneous CpG ODN (PF03512676) in Combination with Trastuzumab in Patients with Metastatic HER2+ Breast Cancer - Article Summary | PDF",1789989830,38]