HER-2 positive

P1/2, N=725, Recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | N=300 --> 725 | Trial completion date: Dec 2025 --> Dec 2026

P1/2, N=725, Recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | N=300 --> 725 | Trial completion date: Dec 2025 --> Dec 2026

Rural patients face lower rates of breast-conserving surgery and treatment delays, attributable to systemic barriers such as limited access to specialist care, high travel costs, and suboptimal care coordination. These findings have important implications for improving equity and collaboration in delivering person-centred breast cancer care.

Similarly, interactions between HER2 IHC score and tpCR, bpCR, or apCR were found in subgroup analyses based on PR status. HER2 IHC 2+ may indicate a decreased tpCR rate, bpCR rate, and apCR rate to neoadjuvant treatment in HR-positive patients having HER2-positive breast cancer, but not in HR-negative patients.

Our findings demonstrate that deep learning, trained to recognize genomic correlates in tissue morphology, can quantify and map subtype admixture in LumA breast cancer that has clinical significance. The low-cost and scalability of this method holds potential as a research tool for investigating ITH and perhaps improving the efficacy of precision oncology.

Furthermore, the sHER2 ECD ECLIA method effectively identifies individuals with HER2-negative status within the low HER2 expression population, thereby providing enhanced guidance for treatment decisions involving antibody-drug conjugates (ADC) in BC patients. Thus, the combined diagnostic approach proposed in this work accurately differentiates between HER2-positive, HER2-negative, and low-expression BC patients, facilitating informed, clinically personalized treatment decisions.

The prevalence of MSI-high tumors among chemotherapy-naïve patients with unresectable GC was 5.6%. These tumors were associated with female sex, older age, lower stomach, HER2-negative, and absence of liver metastasis. These findings would help assuming MSI-high tumors and may have significant implications for clinical practice and studies targeting this GC subtype.

We constructed predictive nomograms and stratified risk to assess the prognosis of patients with HER2 + MBC, which could help inform therapeutic decisions.

We conduct a phase 1b/2 trial to assess the efficacy of combining pembrolizumab (anti-PD1 antibody), exemestane (nonsteroidal aromatase inhibitor), and leuprolide (gonadotropin-releasing hormone agonist) for 15 patients with premenopausal ER+/HER2- MBC who had failed one to two lines of hormone therapy (HT) without chemotherapy. The findings indicate that combining HT with anti-PD1 antibody is a promising treatment strategy for patients with premenopausal ER+/HER2- MBC. This study was registered at ClinicalTrials.gov (NCT02990845).

No significant differences in progression-free survival or overall survival were found in the treatment sequencing groups. There was a higher use of chemotherapy as a first-line therapy, with de novo and "aggressive disease" criteria being the main factors to influence the decision.

P=N/A, N=8, Completed, Masonic Cancer Center, University of Minnesota | Active, not recruiting --> Completed

P1/2, N=71, Recruiting, Yonsei University | Not yet recruiting --> Recruiting | Trial completion date: May 2023 --> May 2025 | Trial primary completion date: Dec 2022 --> Dec 2024

P2, N=186, Recruiting, Alliance for Clinical Trials in Oncology | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Oct 2024 --> Oct 2025

P2, N=138, Active, not recruiting, University of Texas Southwestern Medical Center | Trial completion date: Jul 2025 --> Dec 2029

P1, N=60, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025

The MOUNTAINEER-03 phase III trial is designed to investigate the efficacy and safety of first-line tucatinib in combination with trastuzumab and modified FOLFOX6 (mFOLFOX6) versus standard of care (mFOLFOX6 plus bevacizumab or cetuximab) in patients with untreated HER2+, RAS WT locally advanced unresectable or mCRC...Key secondary endpoints are overall survival and confirmed objective response rate (according to RECIST v1.1 per BICR). Safety assessments will include surveillance and recording of adverse events, physical examination findings, vital signs, cardiac assessments, Eastern Cooperative Oncology Group performance status, concomitant medications, and laboratory tests.Clinical trial registration: NCT05253651 (ClinicalTrials.gov).

P3, N=918, Recruiting, Jazz Pharmaceuticals | Trial completion date: Jul 2025 --> May 2026 | Trial primary completion date: Dec 2024 --> May 2025

P1, N=37, Completed, Bio-Thera Solutions | Active, not recruiting --> Completed | Trial completion date: Mar 2025 --> Jun 2024

The biomarkers identified in this study, including hormone receptor negativity, anatomical Tumour, Node, Metastasis (TNM) Stages 1-2 tumors, positive HER2 amplification, Ki-67 proliferation ≥30%, luminal B/HER2 (+) and HER2 (+) molecular subtypes, are crucial in predicting the likelihood of a complete response to NAT in breast cancer. The presence of these clinicopathologic biomarkers facilitates the process of therapeutic decision-making by identifying patients who are likely to achieve a complete response.

P1/2, N=169, Completed, Cyteir Therapeutics, Inc. | Active, not recruiting --> Completed | Trial completion date: Apr 2025 --> Dec 2024

In the mouse HER2-positive GC model, anti-TIM3 antibodies and trastuzumab demonstrated synergistic anti-tumor effects without toxicity. This study suggests the combined anti-TIM3 antibody and trastuzumab therapy may have potential as a new treatment strategy for HER2-positive GC.

The immune checkpoint inhibitor pembrolizumab in combination with chemotherapy received FDA approval for both PD-L1 positive metastatic and early-stage triple-negative breast cancer, while ongoing clinical trials seek to expand the current treatment landscape for immune checkpoint inhibitors in hormone receptor positive and HER2 positive breast cancer...Studies of cellular therapies such as tumor infiltrating lymphocytes, chimeric antigen receptor-T cells and T cell receptor engineered cells are promising and ongoing. This review provides an update of recent major clinical trials of immunotherapy in breast cancer and discusses future directions in the treatment of breast cancer.

Pyrotinib plus taxanes could be an alternative or even the preferred treatment strategy for patients with HER2-positive MBC after trastuzumab and small-molecule tyrosine kinase inhibitors (TKIs). We also suggest that pyrotinib combined with vinorelbine has a therapeutic potential.

Conclusion Only 8% of patients had positive SLNB in screen-detected breast cancer, which may support the previous studies of omitting SLNB being non-inferior but only in selected postmenopausal small early breast cancers with normal axillary ultrasound in the absence of any other risk factors. However, close follow-up will be required for disease-free survival, overall survival, and locoregional recurrence in this cohort.

This multicenter, single-arm, phase II clinical trial (NCT04034589) evaluated the efficacy and safety of pyrotinib combined with fulvestrant in patients with HR-positive/HER2-positive metastatic breast cancer who had experienced trastuzumab treatment failure. Importantly, no grade 4 or higher treatment-related adverse events or deaths were reported, indicating a favorable safety profile. In conclusion, the combination of pyrotinib and fulvestrant demonstrated promising antitumor activity and acceptable safety in HR-positive/HER2-positive metastatic breast cancer patients.

This study showed no association between HER2 expression and [18F]FDG PET/CT metabolic parameters. However, regardless of HER2 status, the results indicated distant metastasis, local invasion, and vascular invasion could be associated with primary tumor metabolism. PET/CT parameters predict tumor aggressiveness and disease prognosis better than HER2 status.

While chemotherapy and trastuzumab improve survival in early-stage HER2-positive breast cancer, variability in clinical and biological characteristics leads to different response to therapies and outcomes...Key findings show that HER2DX predicts relapse-free survival and probability of pCR to a variety of neoadjuvant therapy regimens, which aids in personalizing treatment plans that could reduce over-treatment and under-treatment. The article underscores expert recommendations to help integrate HER2DX into clinical practice, aiming to enhance decision making and clinical outcomes.

This head-to-head comparison revealed no difference in PFS and OS between PALBO and RIBO, however, a trend to longer PFS and OS with RIBO was observed in the subgroup of patients with TFI <12 months. Side effects experienced with PALBO and RIBO highlight the important toxicities to be addressed during treatment decision.

CCL2 and CXCL12 SNPs are associated with breast cancer susceptibility in overweight and postmenopausal women, and the effect varies according to subtypes. The interaction of SNPs within CXCL12 gene and the association with breast cancer survival further suggest potential targets for improved risk assessment and treatment strategies.

These interventions demonstrate significant potential in preventing cardiac complications and maintaining treatment continuity. Further research should focus on optimizing personalized approaches and evaluating long-term outcomes.

The addition of clinicopathological features slightly altered the AUC values in both tasks. Both radiomics methods based on DCE-MRI and the nomogram are helpful for preoperative prediction of HER-2 expression status.

Under the five-group classification, the overall diagnostic CR was also 82%, with CRs for Luminal A, Luminal B+, Luminal B-, HER2-positive, and TNBC being 86%, 85%, 94%, 88%, and 92%, respectively. This study demonstrates that CNB is highly accurate in differentiating benign from malignant breast lesions, particularly showing significant consistency in the diagnosis of molecular subtypes, providing a reliable reference for clinical diagnosis.

Follow-up showed that HER2-low patients had the worst prognosis compared with HER2-negative (P=0.02) and HER2 positive (P=0.02) and also had the highest progression rate in TCGA cohort (P=0.02); receiver operator characteristic (ROC) model suggested HER2-low could effectively predict prognosis. HER2 expression is closely related to the TNM stage of urothelial carcinoma; HER2 three-tier assessment can effectively predict clinical prognosis of urothelial carcinoma.

The research conducted yielded one compound ZINC11784547 has demonstrated robust binding affinity, favorable ADME features, less toxicity, remarkable stability, and cytotoxic effect. The identified compound holds promise for promoting cancer cell death through CDK12 inhibition.

Our study demonstrated the HR-positive HER2-low breast cancer exhibited a particularity in glucose metabolic profile. Additionally, HER2-zero patients with elevated metabolism were associated with inferior prognosis and warranted careful attention in clinical evaluations.

P1, N=26, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025

P2, N=87, Completed, Nancy Lin, MD | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Aug 2024

P1/2, N=129, Active, not recruiting, Jules Bordet Institute | Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Mar 2025

P2, N=121, Active, not recruiting, SCRI Development Innovations, LLC | Recruiting --> Active, not recruiting

P=N/A, N=600, Recruiting, Jules Bordet Institute | Trial completion date: Jan 2028 --> Jan 2029 | Trial primary completion date: Jan 2027 --> Jan 2028

We found that the HER2 status of CTC in peripheral blood was inconsistent with the histological findings. Further research should explore the clinical significance of detecting HER2-positive CTCs, and it is desired that real-time HER2 status testing of CTCs could hold potential value for patients with breast cancer.

P1, N=26, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Jan 2025 --> Dec 2025 | Trial primary completion date: Jan 2025 --> Jun 2025