Clinical impact of single-gene vs. panel sequencing in advanced HR + /HER2- breast cancer: insights and implications.

Hormone receptor-positive (HR + )/HER2-negative (HER2 - ) breast cancer is the most common subtype, with biomarker-driven therapies improving outcomes. Circulating tumor DNA (ctDNA) analysis enables minimally invasive assessment of somatic alterations to guide therapy. However, assay choice impacts clinical utility, and access remains inconsistent.

The impact of analysis methodology details on invasive breast cancer-free survival in randomized clinical trials.

Background: Standardized endpoint definitions are crucial for the correct interpretation and reporting of clinical trials. In the field of adjuvant breast cancer clinical trials, the Standardized Definitions for Efficacy End Points (STEEP) criteria were introduced in 2007. In 2021, the STEEP criteria were re-assessed, and a new endpoint was proposed: invasive breast cancer-free survival (IBCFS).

Quality-of-life and symptom severity in the PALLAS randomized trial of palbociclib with adjuvant endocrine therapy in early breast cancer (AFT-05, ABCSG-42, BIG-14-03, PrE0109).

Background: The PALLAS phase III, randomized trial investigated whether the addition of 2 years of palbociclib to adjuvant endocrine therapy (ET) improved invasive disease-free survival (iDFS) over adjuvant ET alone. This study reports the patient-reported outcomes (PROs) by treatment arm.

Patients And Methods: A total of 4688 of 5796 PALLAS patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage II-III breast cancer completed PRO measures.

Impact of adding palbociclib on treatment adherence to ongoing adjuvant endocrine treatment in the global randomized PALLAS randomized trial in patients with early breast cancer.

Purpose: Using patient-reported outcomes (PROs) and more objective measures, we evaluated adherence to adjuvant palbociclib and ET in the PALLAS trial, and the impact of palbociclib on ET adherence.

Methods: The open-label, global, phase 3 PALLAS trial randomized patients with hormone receptor-positive (HR+), HER2-negative stage II-III breast cancer (1:1) to either 26 cycles of palbociclib (125 mg/day for 21 days and then 7 days off) plus adjuvant ET, versus ET alone. After 23.

Augmenting Insufficiently Accruing Oncology Clinical Trials Using Generative Models: Validation Study.

Background: Insufficient patient accrual is a major challenge in clinical trials and can result in underpowered studies, as well as exposing study participants to toxicity and additional costs, with limited scientific benefit. Real-world data can provide external controls, but insufficient accrual affects all arms of a study, not just controls. Studies that used generative models to simulate more patients were limited in the accrual scenarios considered, replicability criteria, number of generative models, and number of clinical trials evaluated.