IBRA trial: A Randomized trial to assess clinical utility of LINE-electronic patient reported outcomes for the management of adverse events in breast cancer patients treated with abemaciclib

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: JPRN-UMIN000045432
• Lead Sponsor: Keio University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-13
• Last Update Posted: 17 October 2023
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1) severe hepatic and renal dysfunction (eGFR <30ml/min) 2) interstitial lung disease or a history of the disease 3) dyspnea at rest or requiring oxygen administration 4) a history of administration of CDK4/6 inhibitors 5) preexisting Crohn's disease or ulcerative colitis 6) infectious diarrhea including hemorrhagic colitis or pseudomembranous enteritis 7) preexisting chronic condition resulting in baseline grade 2 or higher diarrhea 8) arrhythmia or uncontrolled heart failure in the past 6 months 9) preexisting ileus or potential condition that may result in ileus 10) history of major surgical resection involving the stomach or small bowel or patients with stoma 11) active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment. 12) personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. 13) contraindicated in the label of abemaciclib; history of severe allergic reaction to abemaciclib. 14) contraindicated in the label of nonsteroidal aromatase inhibitors; females who are pregnant or lactating. 15) a history of allergic reaction to nonsteroidal aromatase inhibitors. 16) contraindicated in the label of loperamide; history of severe allergic reaction to loperamide. 17) not own smartphone or who are not capable of operating LINE application

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of stools increased from baseline per day will be recorded by the LINE-ePRO system during one cycle of abemaciclib treatment (28 days). The sum of the number of bowel movements over 28 days is defined as the AUC. The AUC during 1 cycle will be defined as the primary endpoint.