BackgroundFollowing the completion of treatment and as they enter the follow-up phase, breast cancer patients (BCPs) often recount feeling ‘lost in transition’, and are left with many questions concerning how their ongoing care and monitoring for recurrence will be managed. Family physicians (FPs) also frequently report feeling ill-equipped to provide follow-up care to BCPs. In this three-phase qualitative pilot study we designed, implemented and evaluated a multi-faceted survivorship care plan (SCP) to address the information needs of BCPs at our facility and of their FPs.MethodsIn Phase 1 focus groups and individual interviews were conducted with 35 participants from three stakeholder groups (BCPs, FPs and oncology specialist health care providers (OHCPs)), to identify specific information needs. An SCP was then designed based on these findings, consisting of both web-based and paper-based tools (Phase 2). For Phase 3, both sets of tools were subsequently evaluated via focus groups and interviews with 26 participants. Interviews and focus groups were audio taped, transcribed and content analysed for emergent themes and patterns.ResultsIn Phase 1 patients commented that web-based, paper-based and human resources components were desirable in any SCP. Patients did not focus exclusively on the post-treatment period, but instead spoke of evolving needs throughout their cancer journey. FPs indicated that any tools to support them must distill important information in a user-friendly format. In Phase 2, a pilot SCP was subsequently designed, consisting of both web-based and paper-based materials tailored specifically to the needs of BCPs as well as FPs. During Phase 3 (evaluation) BCPs indicated that the SCP was effective at addressing many of their needs, and offered suggestions for future improvements. Both patients and FPs found the pilot SCP to be an improvement from the previous standard of care. Patients perceived the quality of the BCP-FP relationship as integral to their comfort with FPs assuming follow-up responsibilities.ConclusionsThis pilot multi-component SCP shows promise in addressing the information needs of BCPs and the FPs who care for them. Next steps include refinement of the different SCP components, further evaluation (including usability testing), and planning for more extensive implementation.

Oncology education for post-graduate medical trainees is mostly clinic-based with didactic lectures. However, a 3-4-week rotation lacks full exposure to the vast field of oncology, resulting in an educational gap. We felt there is a need for a standard curriculum to educate trainees on common oncology topics and encourage self-directed learning. This study aims to improve knowledge of oncology in trainees through the use of an oncology educational tool (consisting of a handbook and website) that we developed and evaluated. Fifty-three post-graduate trainees (years 1, 2, and 3) consented to participate at the start of their oncology rotation. In phase I, four participants took part in a usability evaluation of the tool. In phase II, 39 trainees underwent a knowledge assessment with use of the tool. Baseline and post-intervention test results were compared using paired t tests. In the qualitative study (phase III), 10 trainees provided feedback on the updated tool and overall rotation experience. Issues identified from phase I were addressed prior to subsequent phases. Phase II analysis of complete sets of data found the mean post-intervention scores (9.44/10) were significantly higher (p < 0.001) than the mean baseline scores (7.47/10). In the qualitative study, feedback strongly supported the integration of the tool for improving knowledge of trainees. To our knowledge, this is the first study to show that an oncology educational tool for medical trainees improves oncology knowledge by providing a standard curriculum. Future work involves evaluating this tool to determine if effects are from the education tool or rotation experience.

36 Background: The medical specialty of oncology relies heavily on clinical trials to advance policies and practices related to cancer care. However, oncology clinical trial accrual in Ontario has dropped from 12.4% in 2007, to 8.5% in 2009. The objective of this study was to determine barriers experienced by Oncologists and Clinical Research Personnel (CRP) in recruiting patients to oncology trials in Ontario. Methods: In June 2012, an electronic survey was emailed to about 400 oncologists and CRP across Ontario. Variables of interest included demographic data, clinical trial involvement, and perceived barriers to participation in clinical trials amongst three previously identified barrier domains. Barriers were ranked, from 1 (least significant) to 5 (most significant). Statistics were compiled using Graphpad Prism software. Differences in responses were analyzed using the Kruskal – Wallis test and Dunn’s Multiple Comparison Test. Results: Of the 400 emails sent, there were 126 respondents (32%). Of the 126 respondents, 82 fully completed the survey (64.6% useable response rate). Amongst system related barriers, “time related” (Median Agreement (M): 4, Inter Quartile Range (IQR): 3-5), and “resource related” barriers (M: 4, IQR: 3-5) had the most negative effect on accrual (p<0.05). Amongst trial design barriers, “Relevance to patient population” (M: 3, IQR: 3-5), “Deviation from Standard of Care” (M: 3, IQR: 3-5) and “Complexity of Trial Protocol” (M: 4, IQR: 3-5) were the most significant barriers (p<0.05). Lastly, amongst personal barriers, “Commitment of the Principal Investigator/Research Staff” (M: 4, IQR: 3-5) and Drug Safety (M: 4, IQR: 2-4) were the most significant barriers to recruitment (p<0.05). Conclusions: Multiple barriers were identified as having a significant impact on patient accrual in clinical trials. Addressing these barriers prospectively in clinical trial design may benefit future studies to successfully accrue cancer patients. Also, creating clinical trial collaboration vehicles amongst sites in similar geographical areas may contribute to improving patient accrual to clinical trials.

Background: Chemotherapy is the main treatment in patients with pre-treated endocrine-resistant HR+/HER2– metastatic breast cancer, but has limited efficacy and substantial toxicities. The antibody-drug conjugate Dato-DXd consists of a humanized IgG1 mAb targeting TROP2 attached via a stable cleavable linker to a topoisomerase I (TopI) inhibitor payload. Heavily pre-treated patients with metastatic triple-negative breast cancer in the TROPION-PanTumor01 (NCT03401385) study of Dato-DXd showed a manageable safety profile and highly encouraging objective response rates (ORR by blinded independent central review [BICR]: 34% in all patients; 52% in patients treatment-naïve to TopI inhibitor-based therapies). The metastatic HR+/HER2– breast cancer cohort of TROPION-PanTumor01 has completed enrollment (n=41); data are currently maturing. Trial design: TROPION-Breast01 (NCT05104866) is an ongoing, global, phase 3, open-label, randomized trial evaluating efficacy and safety of Dato-DXd vs investigators’ choice of chemotherapy (ICC) in patients with inoperable or metastatic HR+/HER2– breast cancer. Patients (n≈700) are randomized 1:1 to Dato-DXd 6 mg/kg IV Q3W or ICC (eribulin, capecitabine, vinorelbine, or gemcitabine) until progression. Adults with an ECOG performance status of 0–1, who experienced progression on or are unsuitable for endocrine therapy, and received 1–2 prior lines of standard-of-care chemotherapy in the inoperable or metastatic setting are eligible. Monotherapy treatment with inhibitors of mTOR, PD-[L]1, CDK4/6 and PARP do not count as prior chemotherapy lines. Patients must have ≥1 measurable lesion per RECIST 1.1 and an archival or fresh formalin-fixed and paraffin-embedded tumor sample. Clinically inactive brain metastases are permitted. Dual primary endpoints are progression-free survival (PFS) by BICR, and overall survival. Secondary endpoints include PFS per investigator, ORR, disease control rate, patient-reported outcomes, and Dato-DXd pharmacokinetics and immunogenicity. Exploratory endpoints include TROP2 expression and exposure–efficacy relationship. Patients are stratified by number of prior chemotherapy lines, prior CDK4/6 inhibitor use, and region. At the time of writing 236 patients have been enrolled across 19 countries. Citation Format: Aditya Bardia, Kevin Kalinsky, Junji Tsurutani, Erika Hamilton, Joo Hyuk Sohn, Kyong Hwa Park, Yeon Hee Park, Seock-Ah Im, Keun Seok Lee, Daisy Dastur, Vincent Haddad, Sabrina Khan, Binghe Xu, Barbara Pistilli, Hope Rugo. Datopotamab deruxtecan (Dato-DXd), a TROP2 antibody-drug conjugate, vs investigators’ choice of chemotherapy in previously-treated, inoperable or metastatic HR+/HER2– breast cancer: TROPION-Breast01 [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT1-03-04.

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