Prevention or symptomatic reduction of abemaciclib-induced diarrhea in patients with early stage hormone receptor positive (HR+)/HER2-negative breast cancer candidate to receive abemaciclib in clinical practice Digestive System
Conditions
Interventions
Patients are assigned to the control or intervention group based on their willingness to receive prophylactic MBR-01, a standardized probiotic and prebiotic protocol.
Patients in the experimental arm
Sponsors
Azienda Socio Sanitaria Territoriale di Cremona
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Women aged =18 years 2. Histologically confirmed HR+/HER2– early breast cancer at high-risk of recurrence (=4 positive axillary lymph nodes, or 1–3 positive nodes with additional features such as tumor size =5 cm, histologic grade 3, or Ki-67 =20%), candidate to receive abemaciclib 3. Patients were deemed unsuitable for adjuvant chemotherapy due to comorbidities frailty, or patient preference 4. Eastern Cooperative Oncology Group (ECOG) performance status 0–2 5. Adequate hematologic and organ function 6. Ability to provide fecal samples 7. Ability to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Prior exposure to CDK4/6i 2. Chronic diarrheal disorders 3. Inflammatory bowel disease 4. Intestinal resection affecting absorption 5. Systemic antibiotic, proton pump inhibitors or probiotic use within 4 weeks prior to enrollment 6. Immunosuppressive treatment 7. Concurrent participation in another interventional study
Countries
Italy
Contacts
Public ContactMartina Dester
Outcome results
None listed