HER-2 (Human epidermal growth factor receptor 2)

P1, N=24, Active, not recruiting, City of Hope Medical Center | Trial completion date: Feb 2026 --> Jan 2027 | Trial primary completion date: Feb 2026 --> Jan 2027

P2, N=120, Not yet recruiting, Gilead Sciences

P2, N=50, Recruiting, Rutgers, The State University of New Jersey | Not yet recruiting --> Recruiting

Our results highlight CDKN1B as a prognostic biomarker to guide CDK4/6-targeted therapy and a predictor of endocrine resistance in HR + /HER2- breast cancer.

Several of these candidates have entered early-phase clinical evaluation, marking a new era in CDK-targeted therapy. This review synthesizes recent preclinical and clinical advances, defines key challenges in optimizing efficacy and safety, and outlines future directions for integrating CDK-directed strategies within precision oncology frameworks.

The enactment of ISG15 in clinical laboratory practices entails standardized assays, clearly defined decision limits, rigorous quality management, and prospective validation across diverse patient groups. Overall, serum ISG15 is a biologically feasible and analytically measurable candidate biomarker that meets the translational clinical chemistry objectives; however, its clinical implementation requires assay harmonization, outer validation, and incremental validation over the existing laboratory tests.

These strategies underscore the transformative potential of peptide therapeutics to harness the immune system and reshape TME, offering a promising avenue for more effective and durable TNBC treatment. SIGNIFICANCE STATEMENT: With growing interest in peptides as tumor microenvironment modulator, this review provides an in-depth analysis of interactions and crosstalk between immune and tumor cells and explores therapeutic potential of peptides in modulating immune cell signaling pathways, with ultimate impact as anticancer agents for triple-negative breast cancer.

We developed a multiparametric peripheral immune biomarker that integrated baseline and early on-treatment features to predict response to pembrolizumab, which was successfully validated in an independent cohort of 59 patients with breast cancer treated with neoadjuvant dostarlimab. These findings reveal the potential of blood-based immune monitoring to predict immunotherapy benefit, offering an accessible tool for tailoring treatment strategies in breast cancer.

HER2 overexpression is rare in prostatic carcinomas but nearly half show HER2 expression of Score 1 or above. Cases with higher Gleason score and advanced disease stage are more likely to overexpress HER2.

P1, N=42, Recruiting, Johann Wolfgang Goethe University Hospital | Active, not recruiting --> Recruiting | Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Dec 2025 --> Dec 2027

P3, N=246, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Active, not recruiting --> Recruiting | Trial completion date: Mar 2031 --> Jun 2029 | Trial primary completion date: Sep 2030 --> Dec 2028

P2, N=284, Active, not recruiting, National Cancer Center, Korea | Trial completion date: Jan 2027 --> Dec 2027 | Trial primary completion date: Jan 2024 --> Dec 2026