Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced/Recurrent or Adjuvant Setting)
Conditions
Interventions
When loose stools (Bristol Stool Scale type 6 or 7) occur after initiation of abemaciclib, loperamide 1 mg twice daily will be administered and continued with the same dosing schedule until Day 28, ev
Sponsors
Yokohama Asahi Chuo General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with hormone receptor-positive, HER2-negative breast cancer who are scheduled to start abemaciclib treatment - Patients aged 20 years or older - Patients with an ECOG Performance Status (PS) of 0 to 2 - Patients with no prior treatment with abemaciclib - Patients with adequate organ function, as assessed by the treating physician
Exclusion criteria
Exclusion criteria: - 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 n - 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 with diarrhea of CTCAE Grade 2 or higher at baseline - Patients deemed inappropriate for study participation by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative number of Bristol Stool Scale type 6 or 7 bowel movements per patient over 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| <Diarrhea-related> - Weekly cumulative number of Bristol Stool Scale type 6 or 7 bowel movements per patient - Number of days with diarrhea (Bristol Stool Scale type 6 or 7) per patient over 28 days - Incidence of diarrhea (Bristol Stool Scale type 6 or 7) - Incidence of diarrhea of Grade 2 or higher - Incidence of constipation of Grade 2 or higher - Loperamide adherence rate (number of days taken / planned dosing days) <Daily activities / QOL-related> - Interference with daily activities due to diarrhea (proportion of patients affected, number of weeks affected, and weekly interference rates) - Proportion of patients experiencing interference with daily activities in association with maximum CTCAE Grade 1 diarrhea (weekly and over 28 days) - Changes in EORTC QLQ-C30 scores (focusing on diarrhea, physical functioning, and global QOL) | — |
Countries
Japan
Contacts
Public ContactShiro Kawada
Yokohama Asahi Chuo General Hospital Department of Pharmacy
Outcome results
None listed