Abstract PS3-08-14: Typer—A randomized controlled trial evaluating the effect of typology-based coaching on therapy management for patients with hr+/her2- early breast cancer under adjuvant ribociclib treatment

Abstract Endocrine therapy is the backbone of hormone receptor-positive, HER2-negative (HRpos/HER2neg) early breast cancer (eBC) treatment, yet early discontinuation rates are high, compromising long-term outcomes. With ribociclib plus a non-steroidal aromatase inhibitor (NSAI) now approved by the FDA and EMA for eBC at risk of recurrence, it is expected to be widely used in the adjuvant setting. Adjuvant CDK4/6 inhibitor trials show discontinuation in 30-35% of patients. Thus, adherence and persistence are crucial for an effective management of adjuvant ribociclib therapy. Recent studies have highlighted the positive impact of supportive care programs provided by qualified nurses for patients with cancer. Patient-focused motivation techniques and education performed by nurses could strengthen patients’ understanding of the risks and benefits of anticancer treatments. Personalized coaching and structured tools like the “Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool” (MOATT) may strengthen patient engagement and optimize therapy management. TYPER (EU Clinical Trials Number: 2024-520290-12-00) is a prospective, multicenter, randomized, controlled, phase IV study with the objective of investigating the effect of personalized patient coaching on therapy persistence in patients with HRpos/HER2neg eBC receiving adjuvant ribociclib plus NSAI according to the summary of product characteristics (SmPC). In total, 548 patients will be enrolled across 50 study sites in Germany and randomized 1:1 to receive either local routine (control arm) or continuous personalized coaching utilizing the MOATT tool (study arm) during the first 12 months of adjuvant ribociclib therapy. A patient classification model organizes individuals into four distinct groups based on responses to a typology questionnaire. It is based on the idea that personal acceptance of and perceived control over the illness determine the type of support that is most helpful for each individual. The different patient groups therefore call for varied approaches to patient support. Personalized patient coaching will be tailored to individual patient profiles based on patient typology and use the MOATT tool and must be performed by trained (TYPER) coaches. As part of the study, healthcare professionals will be trained to become TYPER coaches. The primary objective is to evaluate the effect of patient education and patient typology-based coaching on persistence, with the primary endpoint being time to permanent ribociclib discontinuation. Secondary endpoints include persistence rates at month 6, 12 and 36, side effect management, and unplanned therapy interruptions. A biomarker program will explore correlations with clinical outcomes. Participants will remain in the study until completion or death, with a maximum individual participation period of 60 months, comprising a 24-month enrollment phase and 36-month follow-up phase. Patient recruitment is planned between Q2/2025 and Q2/2027, with overall study completion expected by Q2/2030. Citation Format: M. Welslau, C. Zeder-Goess, R. Haidinger, B. Welter, B. Aktas, P. Wimberger, P. A. Fasching, H. Kolberg, J. C. Radosa, C. Rudlowski, A. Hein, S. Seitz, D. Fischer, C. Iuliano, C. Mann, M. Braun, V. Mueller, E. Stickeler, M. Thill, N. Ditsch. Typer—A randomized controlled trial evaluating the effect of typology-based coaching on therapy management for patients with hr+/her2- early breast cancer under adjuvant ribociclib treatment [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 PS3-08-14.