Improving clinical trial enrollment rates among patients with operable invasive breast cancers: An ASCO Quality Training Program initiative.

Abstract

e23305 Background: Clinical trial participation is essential for advancing cancer care and recommended in National Comprehensive Cancer Network guidelines. At Kaiser Permanente San Francisco (KPSF), about 5% of patients with early-stage breast cancer enrolled in a clinical trial in 2024, similar to community standards. Through ASCO’s 2025 Quality Training Program, we identified potential barriers to trial enrollment and tested interventions to reach a goal enrollment rate of 20%, more typical of National Cancer Institute-designated cancer centers, in 2025. Methods: After process mapping and surveying key stakeholders including administrators, oncologists, nurses, and patients, we identified a lack of patient and provider awareness of available trials as the biggest perceived barrier to clinical trial enrollment and, using PDSA methodology, tested multiple changes to target this. We modified printed care plans to integrate clinical trial participation and developed a tracking process for a single trial in January 2025, created a standardized electronic note template in March for providers to document clinical trial discussions, and began tracking all early-stage breast cancer trials in June, including patient eligibility and reasons for non-enrollment. Our outcome measure was the percentage of all patients with newly diagnosed operable invasive breast cancer first seen in our oncology clinic from 1/1/2025 to 8/31/2025 who enrolled in a clinical trial at KPSF. Results: In total, 184 new patients were seen in 2024 and 97 in 2025 (through August). Key patient characteristics, including age, race/ethnicity, BMI, clinical stage, and comorbidity burden, were similar between years. Clinical trial enrollment increased from 4.9% in 2024 to 33.0% in 2025, with 6 consecutive months (March through August) exceeding the mean 2024 rate (Table 1). Of 70 non-enrolled patients in 2025, 41.4% were due to lack of trial awareness or tracking; this decreased from 72.7% in January to 0% in August. The trials discussion note template was used by breast oncologists in 49.4% of new encounters since its introduction. Conclusions: A formal quality improvement process can help identify and reduce local barriers to early-stage breast cancer clinical trial enrollment by improving trial awareness and tracking. Future efforts should assess long-term sustainability of our process and generalizability to other cancer types. Clinical trial enrollment rates over time in patients with newly diagnosed operable invasive breast cancers. Year Month (PDSA Cycle) Enrollment Rate 2024 Jan—Dec 4.9% (9/184) 2025 Jan (modified care plans, single trial tracking) 16.7% (2/12) Feb 0% (0/8) Mar (trials discussion note template) 41.7% (5/12) Apr 16.7% (1/6) May 55.6% (5/9) Jun (expanded tracking) 50.0% (9/18) Jul 28.6% (6/21) Aug 27.3% (3/11)