Clinical Trial: Abemaciclib-induced diarrhea and loperamide use during the second and third cycles of abemaciclib: a single-center prospective observational study (AID2 study) (Japan)

Tokyo, Dec. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060032) titled 'Investigation of abemaciclib-induced diarrhea during the second and third cycles of abemaciclib' on Dec. 10.

Study Type: Observational

Primary Sponsor: Institute - Yokohama Asahi Chuo General Hospital

Condition: Condition - Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced/Recurrent or Adjuvant) Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to describe the occurrence of abemaciclib-induced diarrhea (AID) and the actual use of loperamide during the second and third cycles of abemaciclib in patients with hormone receptor-positive, HER2-negative breast cancer. Basic objectives2 - Safety

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - - Patients with hormone receptor-positive, HER2-negative breast cancer receiving abemaciclib treatment - Patients who were enrolled in the previous AID1 study and completed the first-cycle observation period of abemaciclib - Patients who are expected to continue abemaciclib through the third cycle at the time of enrollment in AID2 - Patients aged 20 years or older - Patients with an ECOG Performance Status (PS) of 0 to 2 - Patients deemed by the principal investigator to be able to complete the study diary and questionnaires and to participate in this study Key exclusion criteria - - Patients who did not complete treatment or observation during the first cycle of abemaciclib in the AID1 study - Patients receiving concomitant medications contraindicated with abemaciclib or loperamide - Patients with active infections - Patients with infectious or hemorrhagic enteritis, or pseudomembranous colitis - Pregnant or lactating women, and women of childbearing potential who are unwilling to use effective contraception - Patients with a history of obstructive bowel disease - Patients with inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or a history thereof - Patients who have grade 2 or higher diarrhea at the time of enrollment in AID2 that is considered unrelated to abemaciclib - Patients deemed inappropriate for participation in this study by the principal investigator Target Size - 20

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 12 Month 08 Day Date of IRB - 2025 Year 12 Month 08 Day Anticipated trial start date - 2025 Year 12 Month 10 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068658

Disclaimer: Curated by HT Syndication.