HER-2 negative

P1, N=169, Active, not recruiting, AbbVie | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Dec 2024

P1/2, N=374, Recruiting, ProfoundBio US Co. | N=134 --> 374 | Trial completion date: Sep 2025 --> Apr 2026 | Trial primary completion date: Jan 2025 --> Oct 2025

P2, N=115, Terminated, Zenith Epigenetics | Trial completion date: Dec 2024 --> Mar 2024 | Active, not recruiting --> Terminated; Parts 1 and 2 and Expansion Cohort C were completed. Expansion Cohorts A and B were discontinued based on results from an interim futility analysis and not due to safety concerns.

The most commonly used methodologies were next-generation sequencing and mutation-/allele-specific qualitative polymerase-chain-reaction-based assays. In summary, this recurrent PIK3CA EQA proved to be a suitable approach for quality assessment in predictive molecular biomarker testing, to obtain an international overview of methods used for PIK3CA mutation analysis and to identify the strengths and weaknesses of individual methods.

The results confirm the value of EPclin score as an independent prognostic parameter in node-positive, hormone receptor-positive, HER2-negative early breast cancer patients receiving standard adjuvant treatment. EPclin score can be used to identify patients at higher risk of recurrence who may warrant additional systemic treatments.

Furthermore, the accuracies of 90.11 % for HR+/HR- and 88.89 % for HER2+/HER2- can be reached when evaluating BC patients' molecular subtypes. These results demonstrate that serum SERS combined with powerful LGB-DNN algorithm would provide a supplementary method for clinical breast cancer screening.

Comprehensive assessment of both ORR and safety indicated that CT(A) represents an optimal neoadjuvant therapy for HR+/HER2- breast cancer, whereas AI + CDK4/6 inhibitors rank solely behind chemotherapy. International Platform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY) registration number INPLASY202440092.

These involve lower ODX testing costs, health insurance coverage expansion, re-classification and validation of ODX recurrence scores in patients of minority ancestry, and the development of a faster, more accurate, and affordable test. See related article by Van Alsten et al., p. 654.

This study highlights that BC in young women carries a significant risk of early recurrence, with age, tumor characteristics, and treatment modalities influencing outcomes. The findings emphasize the need for tailored treatment strategies for young BC patients, focusing on surgical precision and aggressive adjuvant therapy for high-risk cases. This research contributes valuable insights into managing BC in younger patients, aiding in improving long-term outcomes.

The mPFS in the Her2-zero group was almost twice that of the Her2-low group, but the difference was not statistically significant. mPFS was significantly longer in the HER2-zero group compared to the HER2-low group in patients receiving ribociclib. More prospective studies are needed to understand the actual consequences of this biomarker.

This study provides further evidence that NCT is a viable treatment option for patients with HER2-negative BC. The TAC regimen resulted in a significantly higher pCR rate compared to other regimens, but did not result in a significant improvement in recurrence, OS and DFS and rates.

P2, N=196, Active, not recruiting, RenJi Hospital | Completed --> Active, not recruiting | Trial completion date: Apr 2023 --> Mar 2031

P=N/A, N=688, Completed, Pfizer | Active, not recruiting --> Completed | Trial completion date: May 2025 --> Feb 2024 | Trial primary completion date: Aug 2023 --> Feb 2024

P=N/A, N=5, Active, not recruiting, University Medical Center Groningen | Recruiting --> Active, not recruiting | Trial completion date: Jan 2024 --> Oct 2024 | Trial primary completion date: Jan 2024 --> Oct 2024

P2, N=30, Recruiting, Chinese PLA General Hospital | Trial completion date: Oct 2023 --> Jun 2025 | Trial primary completion date: Apr 2023 --> Dec 2024

HER2-low status is not a prognostic marker for Taiwanese breast cancer with trivial clinical and pathological differences compared to HER2-zero phenotype. Future studies are warranted to understand the biological and therapeutic relevance of this newly established taxonomy.

Although the nomogram slightly underestimates risk in the Korean population, its high accuracy in identifying low-risk patients suggests a viable alternative to Oncotype DX testing, particularly in settings where the test is not readily available or economically feasible. Further research is needed to refine this tool, ensuring broader applicability and precision across diverse populations.

The changes in blood metabolomes following doxorubicin treatment were dependent on HER2 status, and these changes might serve as severity and prognostic markers of doxorubicin-induced cardiotoxicity.

There was no significant difference in efficacy between abemaciclib and palbociclib and both had good safety profiles. We demonstrated that ALC and NLR might predict the outcomes of CDK4/6i treatment in patients with ER + HER2 - ABC.

Approximately half the patients in both the luminal-type and triple-negative groups were prescribed anthracycline and/or taxane for perioperative chemotherapy. The choice was associated with patient age, cancer stage, and the scale and specialization of the treatment facilities. This study sheds light on the current state of breast cancer treatment practices in Japan.

More than 80% of cN1 patients in our study were eligible for SLNB after NAC. ALND could be avoided in approximately 30% of cases, supporting the role of NAC in reducing the need for ALND among patients with lymph node metastases.

The poor prognosis of patients with high-risk HR+/HER2- BC highlights the need for a better acknowledgement of this subgroup and supports ongoing clinical trials aimed at optimising systemic therapy.

Analysis of somatic mutations by whole exome sequencing showed that counter-intuitively, the cluster of HR + /HER2- samples exhibiting higher immune scores was associated with lower tumour mutational burden, lower homologous recombination deficiency scores, and fewer copy number aberrations, implicating the involvement of non-canonical tumour immune pathways. Further investigations are warranted to determine the underlying mechanisms of these pathways, with the potential to develop innovative immunotherapeutic approaches tailored to this specific patient population.

Although patients with SPBC have worse prognostic tumor characteristics, OS and CSS rates are better than patients with MPC.

Using tumor purity computed from copy number data, we developed a method for estimating cancer cell-specific methylation to confirm that the association to response reflects DNA methylation in cancer cells. Taken together, these results support the potential for clinical benefit of the addition of bevacizumab to chemotherapy when administered to the correct patients.

In 2L, 12 of the 21 (57.1%) patients received CDK4/6i + ET, of which 58.3% received abemaciclib. The two-year overall survival (95% CI) was 97.4% (92.4, 100.0), and the median (range) follow-up was 28.7 (3.4-67.6) months. Despite the limitations inherent in real-world studies and a limited number of patients, these AI-extracted data complement previous studies, demonstrating the effectiveness of CDK4/6i + ET in the Canadian real-world 1L, with most patients receiving palbociclib as CDK4/6i in 1L.

He was given oxaliplatin plus S-1 therapy...The patient underwent adjuvant chemotherapy with docetaxel plus S-1...He underwent second-line therapy with paclitaxel and ramucirumab...He was switched to third-line therapy with nivolumab. He is currently arrive 12 months after surgery.

There was no obvious cancerous remnant in the resected specimen, and the pathological response was Grade 3. The patient was alive and recurrence-free at 4 months postoperatively.

Still, clinicians should be aware that online tools cannot replace the technical datasheet of the drug as well as a comprehensive clinical assessment for each patient. Here we critically review the main pharmacological features of ABE, then focusing on its potential interactions with drugs, food, and alternative medicine, in order to provide a guide for its optimal use in the treatment of HR+/HER2- breast cancer patients.

The significant differences in pCR rates observed in both treatment arms did not significantly impact long-term outcomes for patients treated with cabazitaxel versus paclitaxel in the GENEVIEVE trial.

Low-dose apatinib combined with oral vinorelbine demonstrates potential efficacy and well tolerated for pretreated HER2-negative mBC.

P1/2, N=51, Recruiting, Advanced Accelerator Applications | N=86 --> 51 | Trial completion date: Oct 2025 --> Dec 2026

No abstract available

No abstract available

Clinical Trial Registration Number: NCT03053193

Clinical Trial Registration Number: NCT03053193

Clinical Trial Registration Number: NCT04293393

No abstract available

No abstract available

Clinical Trial Registration Number: NCT05879926

P=N/A, N=600, Recruiting, Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Apr 2023 --> Dec 2024

P=N/A, N=550, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting