Background: Despite recent advances in new therapies for early-stage breast cancer (eBC), the impact of the current treatment landscape on patients’ quality of life remains poorly understood. This study explored the experiences and unmet needs of women with eBC, leading to the development of a patient-informed conceptual disease model (PI-CDM) that summarizes patient priorities. Methods: This qualitative study used a step-wise approach: (1) a targeted literature review; (2) draft CDM development; (3) interview guide development; (4) semi-structured interviews with women in the United States with a diagnosis of eBC; (5) thematic content analysis of interview transcripts; (6) patient steering committee insights; and (7) PI-CDM finalization. Results: Thirty-six women with eBC (stage I, n = 18; stage II, n = 11; stage III, n = 9) were interviewed between December 2023 and May 2024. Key health concepts included signs and symptoms leading to diagnosis and common treatment side effects. Emotional and psychological impacts were prominent, and 28 participants reported moderate to extremely severe anxiety or depression on the EQ-5D-5L. Other impacts included social life, body satisfaction, daily activities, physical functioning, sexual functioning, and finances. Needs for improved communication from healthcare providers about treatment options and better support were emphasized. These insights, combined with patient steering committee recommendations, resulted in a final PI-CDM. Conclusions: This study highlights the substantial burden women with eBC face and provides a framework for future patient-centric research. A CDM developed with patients summarizes the complexity of the eBC experience and can aid discussions between patients and physicians, facilitating shared decision-making to enhance care.

Introduction: With advances in targeted early breast cancer (eBC) treatment, research is needed to understand the factors influencing biomarker testing and respective treatment selection among physicians in routine clinical practice. The purpose of this study was to evaluate factors influencing oncologist decisions for germline BReast Cancer gene (BRCA) mutation (gBRCAm) testing and adjuvant therapy in human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (eBC). Materials and methods: US oncologists completed an online survey from April to July 2024, which included preference exercises to evaluate the relative importance of select factors for gBRCA testing and adjuvant treatment selection in gBRCAm HER2- eBC. Results: Among 150 surveyed oncologists, age was over twice as influential as tumor size and lymph node involvement in gBRCA testing decisions for hormone receptor-positive (HR+)/HER2- eBC. Nearly one-quarter reported that gBRCA test results did not impact their treatment decisions. Olaparib-based regimens were the preferred adjuvant treatment for gBRCAm HER2- eBC, over Cyclin-Dependent Kinases 4 and 6 inhibitors alone for HR+/HER2- eBC, immunotherapy or capecitabine alone for triple-negative eBC, and no treatment. Efficacy was the most important treatment attribute. Oncologists reported that patient unwillingness to undergo gBRCA testing or receive adjuvant olaparib due to cost, treatment duration, or other reasons were barriers to treatment. Conclusions: Despite guideline recommendations, age drives oncologists’ gBRCA testing decisions. To support the preference for olaparib-based adjuvant treatment in gBRCAm HER2- eBC, increased physician awareness of guidelines and the rationale for gBRCAm testing is needed to improve identification of eligible patients.

Background and Objectives: As adjuvant treatment for human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (eBC) evolves, real-world data should inform olaparib utilization, sequencing, and combination patterns in clinical practice. Methods: Using Komodo US claims data (1 January 2019–31 December 2023), we retrospectively analyzed HER2-negative eBC patients on adjuvant olaparib. Continuous insurance for 12 months pre- and ≥30 days post-index date (first olaparib prescription), with follow-up through disenrollment or study end, was required. Outcomes, including time on therapy (Kaplan–Meier median persistence), adherence (proportion of days covered), dose reduction, and combination patterns, were stratified by claims-derived hormone-receptor-positive (HR+) and triple-negative BC (TNBC) status. Results: Among 176 olaparib-treated patients (median age, 44 years), the median (95% CI) time on therapy was 11.0 (9.2, 12.2) months; 27.3% (n = 48) discontinued before 12 months without re-initiating, 19.9% experienced a dose reduction, and median adherence was 90%. Olaparib was combined with other therapies in 48.3% (n = 85) (29.6% [32/108] of TNBC and 77.9% [53/68] of HR+ patients), most often with immunotherapy in TNBC (81.3%, n = 26) and endocrine therapy in HR+ (88.7%, n = 47). Conclusions: Real-world data suggest favorable persistence and dosing patterns with adjuvant olaparib. Future research should prioritize olaparib combination regimen safety and effectiveness.