Abemaciclib for Breast Cancer

(MICRO-VERZ Trial)

This trial aims to explore how the gut microbiome (the collection of bacteria in the digestive tract) changes when people start taking abemaciclib, a common treatment for certain breast cancers, and how these changes might relate to side effects like diarrhea. Participants will receive either a resistant starch supplement or a placebo while continuing their cancer therapy. They will provide stool samples and complete symptom questionnaires. The goal is to better understand gut changes to improve supportive care for those experiencing digestive issues from abemaciclib. Patients with hormone receptor-positive breast cancer who are about to start abemaciclib treatment might be a good fit for this study. As an unphased trial, this study offers patients the opportunity to contribute to research that aims to enhance supportive care for those experiencing digestive issues from cancer treatment.

The trial information does not specify whether you need to stop taking your current medications. It focuses on monitoring the effects of abemaciclib on the gut microbiome and gastrointestinal symptoms.

Research has shown that abemaciclib, a drug for treating hormone receptor-positive breast cancer, is generally effective but can cause side effects. One study found that 49.7% of patients taking abemaciclib with hormone therapy experienced serious side effects, compared to 16.3% who only took hormone therapy. While the drug aids in cancer treatment, it may also cause side effects like diarrhea, affecting daily life.

The FDA has approved abemaciclib for treating certain types of breast cancer, indicating it is considered safe enough to use despite these side effects. This trial tests resistant starch, a type of dietary fiber, alongside abemaciclib. Although specific safety data for using abemaciclib with resistant starch is not yet available, resistant starch is commonly found in foods like potatoes and bananas and is generally considered safe.

Unlike the standard of care for breast cancer, which often involves chemotherapy and hormone therapies, this trial is exploring the addition of resistant starch as a dietary supplement alongside abemaciclib. Researchers are excited about this approach because resistant starch may positively impact gut health and potentially improve the effectiveness or tolerability of cancer treatments. By using resistant starch, this trial aims to explore new ways to enhance treatment outcomes beyond what's achievable with current therapies alone.

Research has shown that abemaciclib effectively treats hormone receptor-positive breast cancer, though it may cause stomach issues like diarrhea. In this trial, participants will receive either resistant starch or a placebo as a dietary supplement during early abemaciclib therapy. Resistant starch might alleviate these side effects. Studies suggest that resistant starch can lower the risk of some cancers and improve gut health, potentially reducing stomach problems for those taking abemaciclib. Although more research is needed, these findings offer hope for better managing side effects.⁶⁷⁸⁹¹⁰