Gut Microbiome Changes During Abemaciclib Therapy in Breast Cancer

Inclusion Criteria:

• Age ≥ 18 years.
• Histologically confirmed hormone receptor-positive, HER2-negative breast cancer.
• Planned initiation of adjuvant abemaciclib (Verzenio) as part of standard clinical care, with enrollment occurring prior to or within 7 days of starting abemaciclib.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Women of child-bearing potential must agree to use contraception prior to study entry, for the duration of study participation, and for 90 days following completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

• Concurrent participation in another interventional clinical trial that, in the opinion of the investigator, would interfere with study participation or interpretation of results.
• Known gastrointestinal conditions that would significantly interfere with study procedures or interpretation of results, including but not limited to inflammatory bowel disease, short bowel syndrome, or chronic diarrheal disorders.
• Known allergy or intolerance to resistant starch or any component of the study supplement.
• Pregnant or breastfeeding individuals.
• Any medical, psychiatric, or social condition that, in the judgment of the investigator, would limit the participant's ability to comply with study procedures.