Racial representation in clinical trials supporting NCCN breast cancer guidelines: A retrospective analysis.

Abstract

1651 Background: Racial disparities in breast cancer are well established, with Black women having disproportionately higher mortality rates. The NCCN guidelines are valuable in the management of breast cancer, highlighting the importance of evaluating racial representation and its trends over time within the studies cited in these guidelines. Methods: We conducted a retrospective analysis of 735 references cited in NCCN Breast Cancer Guidelines Version 4.2025. All clinical trials were included, while reviews, case reports, and non-clinical references were excluded. The primary outcome of interest was the reporting of racial demographics within each reference. Fisher’s exact test was used to assess statistically significant differences in racial representation across time periods. Results: Of 735 references screened, 384 met the inclusion criteria, and 89 (23%) reported racial demographics. Studies reported a total of 87.9% White, 4.5% Black, 4.1% Asian, 0.5% Hispanic, 0.1% American Indian/Alaska Native, 0.0% Native Hawaiian/Pacific Islander, and 0.1% reporting more than one race. Time block 5 had significantly more reported races than blocks 2, 3, and 4 (p-value < 0.05). A statistically significant decrease in percentage reported as White was seen when comparing time blocks 1 to 5 (p = 0.0495), 2 to 5 (p = 0.0336), and 2 to 6 (p = 0.028). Changes in representation among other racial groups were primarily driven by Black and Asian groups, with Asians comprising the largest proportion in time blocks 4 (6.1%) and 6 (17.9%), while the Black race was the largest group in all other time blocks. All other racial groups remained consistently low across time blocks. Conclusions: Only 23% of references reported racial data. While the proportion of the White race decreased over time and an increased representation of other racial groups was observed, the overall reporting of these groups remained low across all time periods. This emphasizes the need for standardized reporting of race in clinical trials to ensure that NCCN guidelines accurately reflect the diversity of patients in breast cancer care. Race demographics from clinical trials cited in the NCCN breast cancer guidelines. Time block Time Bracket Percentage of White Percentage of Non-White Percentage of Black Percentage of Asian Percentage of Hispanic Percentage of AI/AN Percentage of NI/PI Percentage of More than one race 1 1980-1999 95.6% 1.6% 2.8% 0.0% 0.0% 0.0% 0.0% 0.0% 2 2000-2004 92.4% 1.4% 4.6% 0.1% 1.3% 0.0% 0.0% 0.2% 3 2005-2009 86.9% 5.4% 5.2% 1.6% 0.9% 0.0% 0.0% 0.0% 4 2010-2014 88.7% 1.8% 2.8% 6.1% 0.1% 0.0% 0.0% 0.5% 5 2015-2019 87.1% 1.8% 5.7% 4.7% 0.3% 0.3% 0.1% 0.1% 6 2020-2025 78.3% 0.2% 3.1% 17.9% 0.3% 0.1% 0.0% 0.1% Total 87.9% 2.7% 4.5% 4.1% 0.5% 0.1% 0.0% 0.1% AI/AN = American Indian/Alaska Native; NH/PI = Native Hawaiian/Pacific Islander.