TPS625 Background: Mammographic screening programmes reduce breast cancer mortality but detect many small tumours with favourable biology which may not progress. These are treated with surgery and adjuvant therapies, but associated morbidities mean there is a need to reduce overtreatment. Minimally invasive treatments such as vacuum-assisted excision (VAE) have been described but there is no prospective randomised evidence to support their routine use. SMALL (ISRCTN 12240119) is designed to establish the feasibility of using VAE to treat small tumours detected within the UK NHS Breast Screening Programme (BSP). Methods: Phase III multicentre randomised trial comparing surgery with VAE for screen-detected good prognosis cancers. Eligibility criteria are age ≥47 years, unifocal grade 1 tumours (maximum diameter 15mm), strongly ER/PR+ve and HER2-ve, with negative axillary staging. Patients are randomised 2:1 to VAE or surgery, with no axillary surgery in the VAE arm. Excision is assessed radiologically, and if incomplete, patients undergo surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm. Co-primary end-points are 1) Non-inferiority comparison of the requirement for a second procedure. 2) Single arm analysis of local recurrence (LR) at 5 years after VAE. Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure, ensuring sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A QuinteT Recruitment Intervention (QRI) is integrated throughout SMALL to optimise recruitment and informed consent. Recruitment challenges are identified by analysing recruiter/patient interviews, audio-recordings of trial discussions, and by review of screening, eligibility and recruitment data and study documentation. Solutions are developed collaboratively, including recruiter feedback and recruitment tips documents. Results: At 10 th February 2023, 231 patients had been recruited from 32 centres, (~45% of eligible patients), with per site recruitment of 0.4-0.5 patients/month. Based on preliminary QRI findings, a recruitment tips document has been circulated (on discussing SMALL, providing balanced information on treatment options and explaining randomisation), with individual recruiter feedback underway and wider feedback planned shortly. Conclusion: SMALL has excellent recruitment to date, confirming feasibility and acceptability, and is expected to have a global impact on treatment of screen-detected breast cancer. Clinical trial information: ISRCTN12240119 .
e23009 Background: BIG is a global network of > 50 academic research groups conducting large multinational breast cancer (BC) trials. BIG has worked with patient advocates since its inception in 1999. In 2019, the BIG Patient Partnership Initiative (PPI) was launched to deepen the involvement of patient advocates and ensure their perspectives are considered throughout BIG’s research. Many BIG PPI activities have been made possible by EU4Health grants. Methods: To formalize the PPI, a Charter was co-developed by a core team from the BIG headquarters (HQ) and Executive Board (EB), in consultation with patient partners, defining its governance and function. To enable continuous input on all BIG trials, patient partners attend BIG Scientific Meetings where new study proposals are presented. ‘Input Meetings’ are then held to discuss a trial concept with lead investigators, gathering feedback on research questions, study design, eligibility criteria, and endpoints. 1-2 patient partners continue as part of study committees. To inform strategic decision-making, a better understanding of patient partners’ views on various aspects of BC research is sought via virtual and in-person meetings, surveys, and other formats. The insights gathered are shared with the BIG EB. Patient partners also participate in BIG’s scientific activities such as task forces and the BIG-NCTN Annual Meeting. Results: 12 patient partners from 9 countries are currently part of the BIG PPI. Discussions identified 4 pillars for meaningful patient involvement: comprehensive training, systematic integration into BIG’s activities, active participation in strategic planning, and advocacy for patient-centric research within and beyond BIG. 13 training modules have been conducted, covering topics from breast cancer biology and treatment to clinical trial design. 5 Input Meetings have been held leading to the adaptation of 3 new BIG trials to better reflect patient needs. Currently, 7 patient partners are A patient-focused checklist for new trial ideas has been co-developed with the patient partners and piloted with 3 study proposals. Starting in 2025, BIG patient partners will hold 2 seats on the BIG EBA research priorities survey and a research landscape analysis have been conducted with patient partners, BIG HQ, and EB members. Conclusions: BIG is committed to research for and with patients, involving patient advocates who represent the global patient community in its strategy and prioritizing research questions that matter most to them. BIG’s Patient Partnership has evolved as a model for the inclusion of patient advocates in research to develop better trials, which could be applied to other diseases. Support from the European Union has enabled the continued meaningful patient involvement within BIG.
11109 Background: While recent FL therapy advances offer various treatment options, data are limited on FL treatment preferences in the shared decision-making process. A comprehensive survey with a DCE design was conducted to assess preferences of patients, caregivers, and physicians for different attributes that impact treatment choice. Methods: A web-based DCE survey available in English and Spanish was administered in Oct-Nov 2024 to patients with FL, caregivers, and physicians recruited in the US, the UK, Spain, Australia, and Canada through the Follicular Lymphoma Foundation (FLF). FL treatment attributes were selected based on targeted literature review, clinical inputs, and review with FLF patient and caregiver advisors. Attributes included efficacy (progression-free survival [PFS]), safety (impact of adverse events [AEs], including fatigue, cytokine release syndrome [CRS], and neurologic events [NE], on quality of life [QOL]), and convenience (mode of administration, treatment duration and frequency of visits, time needed to travel to treatment center). Survey responses were analyzed by patient, caregiver, and physician groups. Preference weights were generated from conditional logistic regression models and used to calculate the relative importance of attributes and willingness to trade off. Results: A total of 337 patients, 37 caregivers, and 29 physicians (median age: 59, 45, and 51 y, respectively) from 25 countries (>75% from US, UK, and Spain) responded to the DCE survey. The majority (93.7%) of patients reported having experienced ≥1 AE from previous treatment. Patients preferred treatments with longer PFS; mild or no impact of fatigue, CRS, and NEs on QOL during treatment; oral tablets vs infusions; a 3-mo duration with twice-weekly visits vs continuous duration with visits once every 3 mo; and <30 min of travel time vs >2 h (all P <.05). PFS was ranked as the most important attribute across patients, caregivers, and physicians. Following efficacy, treatment convenience attributes were ranked higher by patients and caregivers while safety attributes were more important to physicians. On average, patients were willing to accept reductions of 1 y of PFS for treatment requiring <30 min of travel vs >2 h, 0.7-1 y to receive treatments with less impact of AEs on QOL, 0.6 y for oral tablets vs blood collection and intravenous infusion, and 0.5 y for 3-mo treatment vs continuous duration. Conclusions: Efficacy is the most important attribute in treatment choice for patients, caregivers, and physicians. Following efficacy, patients and caregivers prioritize convenience and reduced impact of AEs, while physicians prioritize safety over convenience. Insights on differences between preferences highlight the importance of informed discussion and a balanced, individualized approach to treatment selection.
e12570 Background: Accurate information about locoregional (LR) treatments following neoadjuvant systemic therapy (NST) for breast cancer is essential for interpretation of oncological outcomes, but reporting is currently poor. We aimed to develop a core outcome set (COS) to improve quality and consistency of LR outcome reporting in trials. Methods: The COS was developed in three phases according to COS-STAD guidance: 1. Generation of a long list of relevant outcome domains from a systematic literature review and stakeholder interviews. 2. Prioritisation of outcome domains using two rounds of an online Delphi survey. 3. An in-person consensus meeting to agree the final COS. Results: In total, 159 unique LR outcomes were identified from phase 1 and categorised into 101 (69 surgical/32 RT) outcomes for survey inclusion. 470 international participants (206 surgeons/144 medical oncologists/98 radiation oncologists) took part in survey Round 1, of whom 336 (71.5%) (153 surgeons/90 medical oncologists/ 77 radiation oncologists) participated in Round 2. After Round 2, 31 outcomes, combined into 15 summary outcomes, were scored as ‘consensus in’, 60 as ‘consensus out’ and 10 as ‘no consensus’. 23 professionals and 5 patient advocates attended the consensus meeting, where ‘consensus in’/’consensus out’ items were ratified, and ‘no consensus’ items discussed. A final 15 item COS for LR outcome reporting was agreed and ratified (Table). Conclusions: A COS for LR treatment reporting in NST trials has been robustly developed using an internationally collaborative approach. Widespread implemention will improve the quality and value of future breast cancer NST trials. Final COS 1 Type of breast and axillary surgery planned before starting NST 2 Proportion of patients not having surgery after NST due to disease progression, treatment toxicities or other comorbidities 3 Number/proportion of patients with a complete response to NST not having surgery to the breast and/or axilla, and how response was assessed 4 How response to NST in the breast and axilla was assessed 5 Type of initial breast and axillary surgery performed after NST 6 Proportion of patients with involved margins after initial and final surgery, and number of procedures required 7 Total number of excised and involved axillary lymph nodes, with extent of involvement 8 Further axillary treatment in patients with ypN+ disease after sentinel node biopsy/targeted axillary dissection (SLNB/TAD) 9 Proportion of patients in whom breast and/or axillary surgery was downstaged 10 Proportion of patients having radiation therapy 11 Indications for radiation therapy at trial level 12 Details of breast/chest wall and nodal targets 13 Details of dose and fractionation to breast/chest wall and nodal areas 14 Receipt of boost; indications for boost (at trial level) 15 Morbidity of locoregional treatments (short/long term as defined in protocol)
