Patterns of breast cancer trial enrollment in a prospective patient database at a comprehensive cancer center.
Authors: Elkhanany Ahmed , Khoury Katia , Jahan Nusrat , Gutnik Lily , Stringer-Reasor Erica Michelle 
Published: June 2024

e23026

Background: Clinical trials (CTs) play a crucial role in expanding the landscape of breast cancer (BC) treatment, improving patient’s (pts) outcome and quality of life. Success of CTs relies heavily on pt recruitment. Understanding barriers for CT non-enrollment (NE) despite opportunities to enroll in real world diverse populations can provide valuable insight into barriers to and facilitators of CT participation. Methods: Coordinators registered pts offered BC trial opportunities at the O’Neal Comprehensive Cancer Center at UAB (University of Alabama at Birmingham) from 12/2020 to 12/2023. Identifiers, ethnicity, race, NE reasons and dates (referral, consent, enrollment, and NE) were recorded. CTs were grouped as Pharmaceutical versus Academic based on sponsorship. Descriptive analysis, Fisher’s exact and Mann Whitney U were calculated using Python. Results: A total of 559 pts were offered a CT with a median age of 55 years. There were 145 pts (27%) enrolled (Gp1), 65 (12%) signed consent with NE (Gp2), and 334 (61%) were NE prior to signed consent (Gp3). Most common NE reason in Gp2 and Gp3 was not meeting protocol eligibility (66% & 43%). Gp3 NE reasons included lack of interest or confidence, insurance and logistics, concern over adverse events, delayed therapy start and change to Standard of Care. In terms of ethnicity and race, most pts were Non-Hispanic White (NHW 312, 56%) followed by Black (NHB 165, 30%). Gp1, Gp2 and Gp3 were 28% vs 15%, 59% vs 56%, 11% vs 15% respectively. NHW pts had higher enrollment to CTs compared to NHB (OR 1.135, p 0.73). For Gp2 and Gp3, patterns of NE were similar among NHW and NHB pts such as lack of interest or confidence (11% in Gp3). In Gp2, More NHB pts had NE due to not meeting protocol eligibility (58% vs 75%). In Gp3, NHW pts had higher NE due to insurance and logistics (8% vs 4%). Median Gp1 consent to enrollment and Gp2 consent to NE were 14 and 11 days. Academic CTs (467, 84%), when compared to Pharmaceutical CTs (92, 16%), had higher enrollment (Gp1 28% vs 16%. OR 2.07, p 0.01). NE reasons did not change significantly between CT types in Gp2 and Gp3. Pharmaceutical CTs had longer median time from referral to enrollment (27 vs 13 days, p 0.001). Of those who signed consent (Gp1 and Gp2), enrollment rate was 69%, with more NHW than NHB pts participating (73% vs 63%, OR 1.56, p 0.19) and more participation to Academic than Pharmaceutical CTs (71% vs 58%, OR 1.77, p 0.18). Conclusions: UAB exceeded the national average of BC CT enrollment (27% vs 9%). Only 50% of NE was related to not meeting protocol eligibility criteria. Issues such as lack of confidence in CTs, concern over adverse events, delayed therapy start date and logistics remain active barriers. NHW and NHB pts had similar enrollment rates, consistent with prior data. NHB pts had higher protocol ineligibility due to more Denovo Stage 4 diagnoses. Academic CTs had better enrollment rate and shorter time to enrollment. Further studies are needed to overcome barriers to enrollment on clinical trials.