Investigation of abemaciclib-induced diarrhea during the second and third cycles of abemaciclib

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060032

Enrollment

Registered

2025-12-10

Start date

2025-12-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced/Recurrent or Adjuvant)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Number of Bristol stool scale type 6 or 7 bowel movements per day	—

Secondary

Measure	Time frame
<Diarrhea-related> - Number of days with Bristol stool scale type 6 or 7 bowel movements and their proportion among all observation days - Proportion of patients with Bristol stool scale type 6 or 7 bowel movements - Proportion of patients with grade 2 or higher diarrhea <Loperamide use> - Total dose of loperamide and total number of loperamide administrations - Proportion of days with loperamide use among days with Bristol Stool Scale type 6 or 7 bowel movements - Proportion of days with scheduled loperamide 1 mg twice daily among days with Bristol Stool Scale type 6 or 7 bowel movements and loperamide use <Others(safety, treatment continuation, and quality of life)> - Proportion of patients with grade 2 or higher constipation - Proportions of patients with dose omission, dose reduction, or discontinuation of abemaciclib primarily due to diarrhea - Changes in EORTC QLQ-C30 scores (diarrhea, physical functioning, and global health status/QoL scales)	—

Measure

Time frame

<Diarrhea-related> - Number of days with Bristol stool scale type 6 or 7 bowel movements and their proportion among all observation days - Proportion of patients with Bristol stool scale type 6 or 7 bowel movements - Proportion of patients with grade 2 or higher diarrhea <Loperamide use> - Total dose of loperamide and total number of loperamide administrations - Proportion of days with loperamide use among days with Bristol Stool Scale type 6 or 7 bowel movements - Proportion of days with scheduled loperamide 1 mg twice daily among days with Bristol Stool Scale type 6 or 7 bowel movements and loperamide use <Others(safety, treatment continuation, and quality of life)> - Proportion of patients with grade 2 or higher constipation - Proportions of patients with dose omission, dose reduction, or discontinuation of abemaciclib primarily due to diarrhea - Changes in EORTC QLQ-C30 scores (diarrhea, physical functioning, and global health status/QoL scales)

—

Countries

Japan

Contacts

Public ContactShiro Kawada

Yokohama Asahi Chuo General Hospital Department of Pharmacy

kawadashirokawada@gmail.com0459216111

Outcome results