If initiated early in the course of GI GVHD, octreotide appears to be an effective, well-tolerated agent in reducing severe voluminous diarrhea. Octreotide should be discontinued within 24 hours after the resolution of diarrhea to avoid the development of ileus. Because no additional reduction in the volume of diarrhea occurred after 7 days of therapy, continuation of the drug beyond this time is not cost effective.

134 Background: Understanding and gaining familiarity with the adverse event (AE) and drug-drug interaction (DDI) potential of novel agents can be challenging, cumbersome, and time consuming for clinicians. A comprehensive and secure AE management/DDI mobile application (CT Scholar [Novartis Pharmaceuticals Corp]) was developed to ease the management of clinical trial participants with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer receiving ribociclib. Methods: CT Scholar was designed specifically for the ribociclib clinical program to provide easy access to information on AE and DDI management. The AE management module characterizes and quickly informs drug-specific AE management based on protocol guidelines and supportive care guidance. The DDI module includes a database of > 100 drugs searchable by both trade and generic name. Number of application visits, unique users, and screen views were monitored from Jan to Sept 2016. Results: There were 1055 visits to CT Scholar (117/month) by 145 unique users (28/month), with 5764 screen views (640/month) and 5.5 screens viewed/visit. Among the most-viewed modules were hematologic AE management (1132 views), gastrointestinal AE management (771), and DDI (734). Diarrhea, neutropenia, and nausea were the most viewed submodules (308, 230, and 205 views, respectively). The information on CT Scholar was consistently shown to be accessed more quickly than information obtained from printed clinical protocols. No patients discontinued from the ribociclib studies due to AEs following the introduction of CT Scholar. Conclusions: CT Scholar was widely used by clinicians, and it responded to their needs by providing essential information, especially on prevalent AEs, which could be easily updated and rapidly accessed. Additionally, CT Scholar provides a platform showing how technology can assist clinicians and patients in managing care during a trial, which can inform the development of future supportive materials.

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 <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 >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.