HER-2 negative

P2, N=60, Recruiting, University of Texas Southwestern Medical Center | Trial primary completion date: Apr 2026 --> Apr 2027

P1, N=60, Recruiting, Immunomic Therapeutics, Inc.

We developed and validated a well-calibrated nomogram for predicting DFS in patients with HR+/HER- breast cancer. This nomogram uniquely integrates MHR with clinicopathological factors to predict prognosis in HR+/HER2- breast cancer and can facilitate individualized therapeutic planning.

Utidelone plus capecitabine has brought therapeutic and survival benefits in the second-line treatment of patients with advanced breast cancer (ABC). Utidelone demonstrates favorable efficacy and safety in patients with refractory ABC, particularly in HR+/HER2- patients. The combination of utidelone with anti-angiogenic therapy shows promising intracranial anti-tumor activity and is expected to be a preferred option for ABC in subsequent lines of treatment.

We recommend a tiered approach of CAB testing in patients with MF/MC BC, whereby, if the first tumor shows CAB-low risk, testing of additional tumor foci is recommended. This approach improves risk stratification and enables tailored adjuvant treatment planning, while minimizing the risk of undertreatment.

Obesity was associated with lower ORR with letrozole alone, whereas this association was not observed in patients treated with taselisib.

These net costs amount to $0.88 per-member-per-month. While introduction of capivasertib could reduce adverse event and follow-up costs, it may result in an overall increase in payers' budget.

Baseline 18 F-FDG PET/CT may provide prognostic insights in HR+/HER2- metastatic breast cancer. High MTV and TLG are associated with poorer OS in univariate analyses but not in multivariable analyses. ECOG score > 0 and age ≥ 60 years are independent predictors of PFS.

These results demonstrate that both dPCR and NGS-based liquid biopsy workflows can be successfully implemented for ESR1 mutation testing in routine clinical practice using locally validated assays. This multicentre verification study provides practical guidance on assay verification, DNA input requirements, and key analytical parameters required to ensure reliable ESR1 mutation detection across different European laboratories. Robust analytical verification of ESR1 testing may improve diagnostic reliability and support personalized treatment strategies for patients with hormone receptor-positive, HER2-negative metastatic breast cancer.

The need for chemotherapy in postmenopausal HR + , HER2- breast cancer patients might be further informed by integrating the results of the Oncotype DX test with the response to NET.

P1/2, N=45, Not yet recruiting, Gilead Sciences Inc.

P1, N=30, Recruiting, University of Texas Southwestern Medical Center | Trial completion date: Apr 2026 --> Apr 2029 | Trial primary completion date: Apr 2026 --> Apr 2028