Abstract PS3-07-18: Barriers to Enrollment in NRG-BR009 in West Virginia: Patient Treatment Preference as a Key Challenge in a Prospective Randomized Trial of Premenopausal Women with Intermediate Oncotype Score

Abstract Background: NRG-BR009 is a phase III randomized trial evaluating whether chemotherapy can be safely omitted in premenopausal women with early-stage, estrogen receptor (ER)–positive, HER2-negative breast cancer and an intermediate Oncotype DX Recurrence Score® (16–25). The trial compares standard chemotherapy plus endocrine therapy to ovarian function suppression (OFS) plus endocrine therapy alone. Despite the clinical promise of de-escalation, national accrual has been limited. This study explores enrollment barriers within the West Virginia University Cancer Institute (WVUCI), a rural-academic network spanning both university and satellite cancer centers. Methods: A real-time Epic-based dashboard was developed to track all patients for whom Oncotype DX testing was ordered from 5/22/2024 to 6/30/2025. Structured interviews with clinical research teams and treating physicians were conducted to assess reasons for enrollment or non-enrollment, focusing on patient decision-making, provider communication, and operational barriers. Results: Among the 177 patients who underwent Oncotype DX® testing during the study period, 166 (93.8%) were female, 20 (11.3%) were under the age of 50, and 21 (11.9%) had a Recurrence Score (RS) greater than 25. Nodal status revealed that 26 patients (14.7%) were node-positive, 125 (70.6%) were node-negative, and 25 (14.1%) had unknown nodal status.Five patients (2.8%) met eligibility criteria for the NRG-BR009 trial. Of these, 4 were treated at the university hospital and 1 at a community site. All 5 patients were node-negative; 1 had an RS between 16–21 and 4 had RS values between 22–25. The clinical trial was offered at the initial oncology consultation. One patient with an RS of 23 enrolled and was randomized to the chemotherapy arm. 3 patients declined participation and subsequently received endocrine therapy with ovarian function suppression (OFS) outside of the trial. One additional patient, with an RS of 16, was recommended OFS by the treating oncologist post-test and was not randomized.Physicians consistently cited both the limited number of eligible patients and strong pre-existing patient treatment preferences as key barriers to enrollment. The trial option was typically introduced during the initial multidisciplinary oncology visit. However, initial interest in NRG-BR009 was low. Many premenopausal patients expressed a preference for chemotherapy prior to surgery but later shifted toward OFS plus endocrine therapy after receiving an intermediate Recurrence Score postoperatively. In most cases, patients had already made a treatment decision by the time of trial discussion and expressed reluctance to accept randomization. Preferences were primarily driven by concerns regarding side effects, fertility preservation, and perceptions of limited absolute benefit from chemotherapy. Conclusions: In a rural-academic cancer network, despite a high enrollment rate 20%, enrollment in NRG-BR009 was limited by both a small pool of eligible patients and strong, pre-existing treatment preferences among premenopausal women with intermediate Oncotype DX scores. Despite timely trial discussions and centralized eligibility tracking, most patients declined participation due to discomfort with randomization and a preference for personalized treatment decisions based on fertility concerns, perceived side effects, and anticipated chemotherapy benefit. These findings highlight the need for earlier engagement in shared decision-making, tailored decision-support tools, and strategies to maintain equipoise when offering clinical trials in preference-sensitive populations. Citation Format: M. Hartzell, J. Hill, G. Monroe, D. Safi, S. Kurian, S. Nethagani, B. Jiang. Barriers to Enrollment in NRG-BR009 in West Virginia: Patient Treatment Preference as a Key Challenge in a Prospective Randomized Trial of Premenopausal Women with Intermediate Oncotype Score abstract. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS3-07-18.