Abstract P4-10-07: Patient-centered initiatives for improving trial participation of diverse patient populations in the open-label phase 3b compLEEment-1 study of ribociclib plus letrozole in the treatment of HR+/HER2- advanced breast cancer
Authors: Small T , Marsano-Feeley J , Fernandez A , Grasso T , Feldman K , Petrone S , Bugazia N , Wong C , Meyer J , Schutta K , Purkayastha D , Saintil K , Spatz Caplan E , Waltman-Johnson K 
Published: February 2018

Abstract
Background: Reported 10-year survival rates in Caucasian, black, and Hispanic women with breast cancer are 80%, 66%, and 78%, respectively. One barrier to understanding disparities in these survival rates is the lack of data due to underrepresentation in clinical trials (including black, Hispanic, Native American, and Pacific Islander populations). US physicians at sites that treat minority patients with breast cancer identified lack of access to and financial burden of clinical trials as 2 key barriers to enrollment. Insufficient knowledge of genetic mutations specific to breast cancer is also a key barrier to identifying ideal treatment to extend survival in minorities. Patient-specific initiatives for the CompLEEment-1 study (CLEE011A2404; NCT02941926), a single-arm, international Phase 3b study of ribociclib (600 mg/d, 3 weeks on/1 week off) plus letrozole (2.5 mg/d) in adults with hormone receptor–positive, human epidermal growth factor–negative advanced breast cancer, were developed in the United States to increase the enrollment of diverse populations and better understand the disease and patient response to treatment.
Methods: The enrollment initiatives included formation of a board of leading physicians and academics to advise on awareness initiatives and the cultural competency of tools used in clinical trials, a site selection process that brought the trial to the patient's clinic, a simplified expense reimbursement program to reduce patient economic burden, and partnerships with the Bridge Group and the National Black Church Initiative to bring clinical trial awareness and education to the African American church community. A tumor collection companion study (NCT03050398) was created to identify mechanisms of resistance among racial and ethnic groups. These initiatives aimed to increase the percentage of minorities from previous trials (eg, 5.7% in the MONALEESA-2 trial) and identify potential biological differences associated with race or ethnicity that might affect treatment response.
Results: Enrollment in the CompLEEment-1 study is ongoing. Among the first 57 US patients enrolled, 8 (14.0%) were minorities (not identified as Caucasian or Asian), 32 (56.1%) were &lt;65 years old, 7 (12.3%) were premenopausal women, and 2 (3.5%) were men. Thirty-one patients were enrolled in the simplified expense reimbursement program. Of the open study sites, 35 (52.2%) were located &gt;30 miles outside of metropolitan areas. Of the open study sites with enrolled patients, 16 enrolled 1, 8 enrolled 2, and 5 enrolled ≥3 patients.
Conclusions: Following discussions with physicians and assessments of patient feedback to identify reasons for underrepresentation of minority patient populations in clinical trials, patient-centered initiatives were developed for the CompLEEment-1 study in the United States to simultaneously reduce barriers to trial participation, reduce economic burden of enrolled patients, and identify biomarkers of therapeutic sensitivity and resistance. These initiatives resulted in an initial increase in the percentage of minorities enrolled to better reflect real-world populations.
Citation Format: Small T, Marsano-Feeley J, Fernandez A, Grasso T, Feldman K, Petrone S, Bugazia N, Wong C, Meyer J, Schutta K, Purkayastha D, Saintil K, Spatz Caplan E, Waltman-Johnson K. Patient-centered initiatives for improving trial participation of diverse patient populations in the open-label phase 3b compLEEment-1 study of ribociclib plus letrozole in the treatment of HR+/HER2- advanced breast cancer [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P4-10-07.