HER-2 negative

In this population-based cohort study of patients with HR+/HER2-breast cancer, the use of NACT seems to be comparable to adjuvant chemotherapy in terms of prognosis, although non-inferiority cannot be proven by this study design. Until further evidence suggesting a survival benefit in favor of either treatment is available, NACT can be pursued when surgical-de-escalation is intended.

In this population, axillary surgery varies more within surgeons than between surgeons, suggesting that surgeons are not taking an "all-or-nothing" approach. Comorbidities, frailty, and age accounted for a small proportion of the variation, suggesting nuanced decision-making may include additional, unmeasured factors such as differences in surgeon-patient communication.

Meanwhile, the ICIs plus chemotherapy group demonstrated significantly improved objective response rate (ORR) (50.9% vs. 27.6%; P=0.03) and disease control rate (DCR) (98.3% vs. 82.8%; P=0.01), and the side effects were tolerable. In summary, for HER2-negative AGC, ICIs plus paclitaxel-based chemotherapy is effective with mild toxicities, which should be considered as an alternative first-line therapy regimen.

Atypical ILCs have distinct characteristics. They are more frequently of a higher grade and demonstrate a superior response to NACT. Despite the latter, atypical ILCs have a worse 5-year DFS which should be taken into consideration in terms of prognostication and may assist patient selection for NACT.

The benefit derived from ICIs plus chemotherapy is similar between Asian and global GEAC patients. However, those with a PD-L1 CPS < 5 or CPS < 10 may not have significant benefits from ICIs therapy. Therefore, it is advisable to routinely assess PD-L1 expression in GEAC patients considered for ICIs treatment.

We report a case of an 87-year-old female with advanced, pMMR/MSS, HER2-negative, ARID1A-mutant, undifferentiated carcinoma of the esophagus with a PD-L1 CPS of 20, who has shown a durable ongoing response to pembrolizumab monotherapy for 2 years now. The case highlights a favorable response, possibly attributed to the high CPS score combined with the ARID1A mutation, as recent research suggests that ARID1A mutations may increase immunotherapy susceptibility.

Estimated 5-year overall survival was 89.8% (95% CI 86.0-93.6). In conclusion, although some of IBTR cases could have been prevented by adaptations in biopsy techniques and patient selection, BCS followed by IORT was associated with a substantial risk of IBTR.

In young patients with HER2-negative BC and germline BRCA1/2 PVs, HER2-low disease was less frequent than expected and more frequently linked to BRCA2 PVs and associated with luminal-like disease. HER2-low status was associated with a modestly improved prognosis.

The oncologic safety of BCS after NAC and NET has been established in prospective trials, and local recurrence (LR) rates are acceptably low provided negative surgical margins can be obtained. Investigation is under way to determine the feasibility and safety of omitting breast surgery in patients with responsive subtypes who have no residual invasive or in situ disease identified on post-treatment tumor bed biopsies; however, the significant risk of missing residual disease-which may impact selection of adjuvant systemic therapy-may preclude future adoption of this approach.

Notably, trastuzumab deruxtecan (T-Dxd), an ADC that specifically targets HER2, has recently received approval from the US Food and Drug Administration as the inaugural targeted therapeutic option for HER2-low BC...By synthesizing available evidence, the objective is to contribute to an enhanced understanding of HER2-low BC, providing a foundation for more informed clinical decisions and further advancements in tailored therapeutic approaches. As the medical community navigates these uncertainties, this review seeks to consolidate existing knowledge, fostering a collective effort toward establishing consensus in the diagnosis and treatment of HER2-low BC.

This consensus provides a comprehensive overview of BC immunotherapy, including immunotherapy for early-stage BC and late-stage BC, immune related adverse event (irAE) management, biomarkers of immunotherapy, and future directions. The consensus consolidates these deliberations into 15 evidence-based recommendations, serving as a practical guide for clinicians to more scientifically and systematically manage the clinical application of immunotherapy.

No abstract available

Common non-hematological toxicity occurred in abemaciclib group was diarrhea (27.4%), and were increased aspartate aminotransferase (AST) (26.3%), nausea (25.0%), vomiting (11.8%) and hypokalemia (13.2%) in tucidinostat group. Our study suggests superiority of abemaciclib-based therapy over tucidinostat-based therapy in patients progressed on palbociclib, which merits further assessment in larger and prospective trials.

No abstract available

P1, N=24, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended

P1/2, N=154, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=320 --> 154 | Trial completion date: Jan 2026 --> Mar 2025

More active treatment methods, like chemotherapy, mastectomy and postoperative radiotherapy, could improve the prognosis of CUPAx. The differential mutation genes of CUPAx and BCAx might be associated with their respective biological behaviors like invasiveness and prognosis.

SG was associated with an HRQoL benefit in most symptoms and functioning, compared with TPC. This supports the favorable profile of SG as a treatment option for patients with pretreated HR+/HER2- mBC.

This would provide patients with ER-low tumors the same treatment opportunities as patients with TNBC, within studies and within clinical routine. This work was financially supported by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, in accordance with terms and conditions of a Master Collaboration Agreement between the company and Karolinska Institutet.

In this real-world data (RWD) study, a significantly higher breast pCR rate was found in HER2-low BC than in HER2-0 BC, although there was no significant difference in survival. Moreover, ER expression had a significant prognostic impact on HER2-low BC.

Compared with IDC, PMBC demonstrated superior RFI, RFS, and OS. Lymph node negativity, adjuvant radiotherapy, and endocrine therapy were associated with superior RFI. Adjuvant chemotherapy was not associated with better outcomes.

This study supports the interpretation of HER2 status as a possible prognostic and predictive biomarker for HER2-negative eBC, especially among patients with ER+ disease.

P1, N=45, Recruiting, George T. Budd | Trial completion date: Sep 2024 --> Mar 2025 | Trial primary completion date: May 2024 --> Nov 2024

P2, N=137, Recruiting, Dartmouth-Hitchcock Medical Center | N=28 --> 137

P=N/A, N=472, Completed, Pfizer | Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Feb 2024 | Trial primary completion date: Jun 2024 --> Feb 2024

P=N/A, N=68, Completed, Duke University | Active, not recruiting --> Completed | Trial completion date: Nov 2023 --> Jul 2023 | Trial primary completion date: Nov 2023 --> Jul 2023

P=N/A, N=779, Completed, Pfizer | Active, not recruiting --> Completed | Trial completion date: May 2024 --> Jan 2024 | Trial primary completion date: May 2024 --> Jan 2024

The calibration curve showed that the multimodal radiomics model had a high consistency with the actual results in predicting HER-2 expression. T2WI, ADC and early-delayed phase DCE-MRI imaging histology models for HER-2 expression status in breast cancer are expected to provide a non-invasive virtual pathological basis for decision-making on preoperative neoadjuvant regimens in breast cancer.

In the high Ki-67-PI group: low ODX-RS in 12%, intermediate ODX-RS in 48%, and high ODX-RS in 40%. In conclusion, the results show no significant correlation between the ODX-RS and Ki-67-PI (r = 0.511, p-value < 0.9).

P1, N=52, Terminated, Exelixis | N=373 --> 52 | Trial completion date: Oct 2024 --> May 2024 | Active, not recruiting --> Terminated; Business reasons

P3; Trial completion date: Mar 2024 --> Oct 2032

P2, N=201, Active, not recruiting, Priscilla McAuliffe | Trial completion date: Mar 2025 --> Jul 2024 | Trial primary completion date: Mar 2024 --> Jul 2024

P1/2, N=66, Active, not recruiting, Stephen Shiao | Trial primary completion date: Mar 2022 --> Dec 2024

P2, N=52, Active, not recruiting, Borstkanker Onderzoek Groep | Recruiting --> Active, not recruiting | Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: Sep 2023 --> Jan 2024

The DESTINY-Breast04 trial results showed that trastuzumab deruxtecan (T-DXd) significantly prolonged the survival of patients with HER2-low breast cancer, thus presenting a paradigm shift in anti-HER2 therapy...We inferred that the HER2-low and HER2-zero statuses do not affect the RFS and OS of patients with ER-positive breast cancer. The prognostic significance of HER2-low or HER2-zero status in luminal A- and B-like breast cancers might differ, and a new treatment strategy is required for the HER2-low subgroup.

P2, N=240, Active, not recruiting, AstraZeneca | Trial completion date: Mar 2024 --> Mar 2025

P1/2, N=188, Recruiting, Cancer Research UK | N=114 --> 188 | Trial completion date: Sep 2025 --> Jun 2027 | Trial primary completion date: Sep 2025 --> Jun 2027

P2, N=70, Active, not recruiting, Hope Rugo, MD | Recruiting --> Active, not recruiting

P1, N=150, Active, not recruiting, AbbVie | Trial completion date: Nov 2023 --> Sep 2024 | Trial primary completion date: Nov 2023 --> Sep 2024

P2, N=25, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Mar 2024 --> Dec 2026 | Trial primary completion date: Mar 2024 --> Dec 2026

P2; Not yet recruiting --> Recruiting

Although clinical benefit of prolonged VEGF blockade after disease progression has not been confirmed in gastric cancer, combination therapy of cytotoxic agents and anti-VEGF agent, such as irinotecan plus ramucirumab demonstrated favorable objective response rate and progression-free survival in third- or later-line setting. In this review, we discuss recent progress and future directions of later-line treatments of HER2-negative advancer gastric cancer.