Probiotics to Help Abemaciclib-Treated Breast Cancer Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial investigates the effect of a synbiotic supplement (probiotics, prebiotics, and postbiotics) added to standard care for breast cancer patients treated with Abemaciclib. Participants are adults with hormone receptor-positive early breast cancer who require adjuvant endocrine therapy in combination with Abemaciclib and have recovered from prior chemotherapy toxicities. The study uses a crossover design where participants receive both the synbiotic and placebo in different periods over four months, alongside standard anti-diarrheal medications as needed and ongoing cancer treatment. Blood tests will be used to assess metabolic factors in addition to tracking gastrointestinal symptoms. The trial aims to determine if the synbiotic can lessen abdominal discomfort beyond what is achieved with conventional care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

A. Adults with hormone receptor-positive (HR+) early breast cancer were confirmed.

B. At least 18 years old at the time of signing the informed consent. C. Candidates for adjuvant endocrine therapy in combination with Abemaciclib (either NHI-reimbursed or self-funded), as determined by the primary treating physician. Prior chemotherapy requirement: Must have completed prior adjuvant chemotherapy at least 21 days before enrollment. All chemotherapy-related toxicities (except alopecia or Grade 2 peripheral neuropathy) must have resolved to ≤ Grade 1.

D. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

E. Adequate bone marrow function as defined by:

1. Absolute Neutrophil Count (ANC) ≥ 1,500/μL without G-CSF support within 14 days of enrollment.
2. Platelet count ≥ 100,000/μL.
3. Hemoglobin ≥ 8.0 g/dL (red blood cell transfusion is permitted prior to enrollment).

F. Adequate hepatic function, as defined by:

1. Serum alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 3× the upper limit of normal.
2. Total bilirubin (T-bil) ≤ 1.5× the upper limit of normal. G. Willingness to refrain from using any other oral probiotics or prebiotics from the first dose of the study intervention ("Synbiotic Supplement" or placebo) through study completion.

H. Ability to communicate with study personnel and willingness to comply with study visits, treatment plans, and other trial regulations.

Exclusion Criteria:

A. Currently pregnant or breastfeeding. B. Received systemic antibiotic therapy for active viral, bacterial, or fungal infections within 2 weeks before the first dose of the study intervention.

C. Severe pre-existing medical conditions that, in the investigator's judgment, preclude participation, including but not limited to the following:

1. Severe renal impairment (e.g., estimated creatinine clearance \< 30 mL/min).
2. Interstitial lung disease.
3. Severe dyspnea at rest or the requirement for oxygen therapy.
4. History of major gastrointestinal surgeries, such as gastrectomy or small bowel resection.
5. Pre-existing Crohn's disease, ulcerative colitis, or other chronic conditions that cause clinically significant diarrhea.

D. History of the following cardiovascular conditions: syncope of cardiovascular origin, ventricular arrhythmias of pathological origin (including ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: Patients with atrial fibrillation that is controlled and stable for at least 30 days before randomization are eligible.

E. Unwillingness or inability to provide written informed consent.

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Chiao-Wei Lin
• Email: cwlin@lwhklab.com.tw
• Phone: +886-2-2377-2318

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.