HER-2 negative

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.

Fasting mimicking diet was well tolerated during chemotherapy and reduced toxicity of chemotherapy and also, had beneficial effects of some metabolic parameters. https://irct.behdasht.gov.ir/user/trial/61386/view.

One-quarter of patients with HR+ HER2- MBC initiating palbociclib report rapidly emergent clinically meaningful fatigue, often with severe symptoms and functional interference. Treatment-emergent fatigue is associated with both pretreatment (lower ANC levels, longer sleep duration) and on-treatment (long sleep duration) hematologic and nonhematologic profiles.

P2/3, N=374, Recruiting, Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Dec 2024 --> May 2025 | Trial primary completion date: Nov 2024 --> May 2025

P2, N=379, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Nov 2024

P=N/A, N=30, Not yet recruiting, Walter and Eliza Hall Institute of Medical Research

P1, N=200, Active, not recruiting, Genentech, Inc. | Trial completion date: Nov 2024 --> Dec 2026 | Trial primary completion date: Nov 2024 --> Dec 2026

P2, N=147, Active, not recruiting, Jules Bordet Institute | Trial primary completion date: Sep 2024 --> May 2025

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.

Palbociclib, abemaciclib, and dalpiciclib demonstrated comparable efficacy in Chinese patients with advanced HR+/HER2- MBC. ClinicalTrials.gov identifier: NCT06344780.

Treatment distribution was as follows: 15 patients received palbociclib (38%), 19 ribociclib (49%), and five abemaciclib (13%). Most patients received fulvestrant (31 patients, 79%), whereas eight patients (21%) were treated with letrozole...FDG-PET-CT performed before cyclin-dependent kinase 4/6 inhibitor commencement is a valuable prognostic tool in hormone receptor-positive human epidermal growth factor receptor 2-negative advanced breast cancer. Patients with SUVmax less than 8.4 experienced extended progression-free survival compared to those with higher SUVmax.

e-Pharmacophore model was generated using Receptor-Ligand complex using the Inavolisib drug (PDB:8EXV) and phase screening was performed using the Molport database of natural compounds...These compounds demonstrated favorable results in several parameters, including RMSD, RMSF, Rg, SASA, PCA, FEL, and total energy evaluations. Therefore, these compounds are projected to function as PI3K-α inhibitors and because of its natural origin it can possess fewer side effects than the conventional medicine, which should be validated by proper in vivo and in vitro models.

Adding ICIs to first-line treatment significantly prolongs survival in overall patients and in those with PD-L1 CPS 1-4 or unknown. This study also provides valuable insights into prognostic markers and resistance mechanisms, potentially guiding immunotherapy strategies.

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.

HOXB13 is frequently co-gained with ERBB2 at both low-copy number level or as complex high-level amplification with relative BRCA1 loss. ERBB2/HOXB13 amplified, BRCA1-lost tumors are strongly enriched in breast cancer, and patients with such breast tumors experience a shortened PFS.

P3, N=510, Active, not recruiting, Olema Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting

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

Quality of life was maintained when palbociclib was added to letrozole in Asian women with ABC. These findings are consistent with PALOMA-2 results and support the use of palbociclib as first-line treatment in postmenopausal Asian patients with ER+/HER2- ABC.

Across the Nordic countries, incidence of BC in women aged 80+ increased. In Denmark, rising incidence of BC is driven by the ER+/HER2- subtype in the 80+ group, which has the best prognosis and gentle treatments. More elderly BC patients will require treatment and follow-up in the future.

Abemaciclib+fulvestrant significantly improved PFS after disease progression on prior CDK4/6i+ET in patients with HR+, HER2- ABC, offering an additional targeted therapy option for these patients.

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.

P3, N=2017, Active, not recruiting, Karolinska University Hospital | Unknown status --> Active, not recruiting | Trial completion date: Jan 2022 --> Jan 2028

P1/2, N=106, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Dec 2024 --> Jun 2025

Although trastuzumab deruxtecan improves the prognosis of patients with HER2-low breast cancer, the characteristics and prognostic value of low HER2 status remains to be elucidated...Multivariate logistic regression analyses revealed that HER2-low status was not an independent factor for OS. The findings of the present study suggest that HER2-low status may not have a significant association with prognosis, despite a significant association between Ki67 and hormone receptor expression.

It is typically responsive to anthracycline/taxol-based conventional chemotherapy...These data identify potential mechanistic leads for anti-proliferative and pro-apoptotic effects of DF in the present TNBC model. The present experiments validated a mechanism-driven experimental approach to identify efficacious nutritional herbs and/or their bioactive constituents as treatment alternatives for TNBC.

P2, N=44, Active, not recruiting, University of Malaya | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2026 | Trial primary completion date: Apr 2023 --> Dec 2025

P2, N=70, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Nov 2025 | Trial primary completion date: Dec 2024 --> Nov 2025

This case highlights the need for awareness of acute, severe hyperglycemia as a potential adverse effect of capivasertib and similar oncologic agents. Clinicians should ensure at least twice weekly blood glucose monitoring for any degree of capivasertib-induced hyperglycemia, and have high suspicion for this contributing factor in cases of severe hyperglycemia.

This extensive data pool suggests significant benefit of CDK4/6i regimens after disease progression as compared with ET monotherapy. Our data also support current guideline recommendations of ET-based therapies over chemotherapy for treatment sequencing.

P1/2, N=46, Terminated, Henan Cancer Hospital | Trial completion date: Jan 2026 --> Jul 2024 | Active, not recruiting --> Terminated; Investigators' decision

In hormone receptor-positive, HER2-negative breast cancers, a growing number of revolutionized personalized therapies are in clinical use or on trials, such as CDK4/6 inhibitors and immune checkpoint inhibitors in adjuvant and neoadjuvant settings, and PIK3CA inhibitors in metastatic disease. In this review, we focus on biomarkers associated with those new therapeutic targets and molecular applications for genetic alterations associated with drug resistance or interaction from a pathology perspective for selecting and optimizing breast cancer treatment.

Five-profile classification provides a more accurate idea about the rate of potential change in treating BC in the metastatic setting.

Our study showed differences between in situ and invasive biomarker expression. According to our findings, owing to heterogeneity, in situ components can't be representative of invasive components for treatment choices.

CT-defined low SMD predicts poor treatment outcomes in patients with ABC undergoing first-line treatment with aromatase inhibitors and CDK4/6i.

By analyzing clinical evidence, commercial presence, reimbursement mechanisms, guideline recommendations, regulatory pathways, and local experiences, this study reveals the complex factors that influence the adoption of personalized medicine technologies. By highlighting these challenges, this article offers valuable insights into strategies to facilitate the integration of innovative diagnostic tools into clinical practice across Europe, ultimately leading to improved treatment decision-making for cancer patients.

This multicenter retrospective cohort study included 158 patients aged ≥70 years diagnosed with HR+/HER2-negative metastatic breast cancer who received either standard or reduced doses of CDK4/6 inhibitors (Ademaciclib, Ribociclib, Palbociclib) as first-line therapy. Palbociclib at standard dose may offer superior outcomes. These findings support personalized dosing strategies to optimize efficacy and tolerability in frail or elderly patients.

In conclusion, PD-L1 expression in TNBC shows significant discordance post-treatment, highlighting the need for routine testing and further research on predictive biomarkers.

We observed significant positive patient-level correlations between DFS and OS, IDFS and OS, and DDFS and OS in early-stage HER2- BC. Our IDFS and DDFS findings advance the understanding of the role of these DFS endpoints as predictors of OS, and their potential utility as surrogate endpoints in clinical trials of early-stage HER2- BC, given additional validation in trial-level meta-analyses.

The PFS benefit was more pronounced in those individuals who received abemaciclib or ribociclib as second CDK4/6i. Continuation of CDK4/6 inhibition was associated with higher rates of grade 3 and 4 neutropenia (range: 25-40%) and anemia (range: 1.7-11%). In conclusion, switching CDK4/6i and ET conferred a statistically significant improvement of PFS in comparison to ET alone in patients with progression or recurrence on prior CDK4/6i-containing therapy.

P=N/A, N=25, Active, not recruiting, Centre Oscar Lambret | Recruiting --> Active, not recruiting | Trial completion date: Sep 2023 --> Sep 2025 | Trial primary completion date: Sep 2023 --> Sep 2025