Evidence map›Paper›PMID 42235180›Full record

ArticleBreast (Edinburgh, Scotland)2026

A mixed prebiotic/probiotic intervention (MBR-01) for the management of diarrhea during abemaciclib treatment of early breast cancer in postmenopausal patients: A single-center prospective case-control pilot study.

Daniele Generali, Alexandro Membrino, Alessandra Fontana, Federica Gattazzo, Carla Strina, Manuela Milani, Valeria Cervoni, Aldo Caltavituro, Andrea Castagnetti, Sergio Del Bianco and 1 more

Abstract read
In one paragraph

Article in Breast (Edinburgh, Scotland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Daniele GeneraliMultidisciplinary Unit of Breast Pathology and Translational Research, ASST of Cremona, Cremona, Italy; Department of Medicine, Surgery and Health Sciences, University of Trieste, Cattinara Hospital, Trieste, 34128, Italy. Electronic address: daniele.generali@asst-cremona.it.
Alexandro MembrinoDepartment of Medicine, Surgery and Health Sciences, University of Trieste, Cattinara Hospital, Trieste, 34128, Italy.
Alessandra FontanaDepartment for Sustainable Food Process-DiSTAS, Università Cattolica Del Sacro Cuore, Piacenza, Italy.
Federica GattazzoDepartment of Medicine, Surgery and Health Sciences, University of Trieste, Cattinara Hospital, Trieste, 34128, Italy.
Carla StrinaDepartment of Medicine, Surgery and Health Sciences, University of Trieste, Cattinara Hospital, Trieste, 34128, Italy.
Manuela MilaniDepartment of Medicine, Surgery and Health Sciences, University of Trieste, Cattinara Hospital, Trieste, 34128, Italy.
Valeria CervoniDepartment of Medicine, Surgery and Health Sciences, University of Trieste, Cattinara Hospital, Trieste, 34128, Italy.
Aldo CaltavituroClinical and Translational Oncology, Scuola Superiore Meridionale, Naples, Italy; Translational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.
Andrea CastagnettiWellmicro Srl, Via Bruno Rizzi 1, Bussolengo, VR, 37012, Italy.
Sergio Del BiancoPrecision Oncology Department, Sanatrix Clinic, Rome, Italy.
Francesco SchettiniTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; Clinic Barcelona Comprehensive Cancer Center, Hospital Clinic Barcelona, Barcelona, Spain. Electronic address: schettini@clinic.cat.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdjuvant abemaciclib + endocrine therapy (ET) improves long-term outcomes in high-risk, hormone receptor-positive (HR+)/HER2-negative early breast cancer (eBC). However, treatment is frequently complicated by diarrhea, affecting adherence and quality-of-life (QoL). Increasing evidence suggests that abemaciclib-induced gastrointestinal toxicity may involve gut microbiota alterations. We conducted a prospective case-control pilot study evaluating the efficacy of MBR-01, a standardized prebiotic/probiotic formulation, in mitigating abemaciclib-induced diarrhea.

methodsWe enrolled 20 postmenopausal patients with high-risk HR+/HER2-negative eBC considered unfit for adjuvant chemotherapy. Patients received abemaciclib + letrozole (control, n = 10) or abemaciclib + letrozole + MBR-01 (experimental, n = 10). The primary endpoint was the incidence and severity of diarrhea; secondary endpoints included treatment adherence, QoL assessments and exploratory baseline/week-12 microbiota characterization according to treatment arm. TRIAL REGISTRATION NUMBER: ISRCTN11948182.

resultsDiarrhea occurred in all patients. In the control group, diarrhea was predominantly grade 1 (50%) or grade 2 (40%), with one grade 3 event (10%). In the MBR-01 group, diarrhea frequency and severity were reduced by ∼70% at the end of week-12; 90% of patients experienced only grade 1 diarrhea or none by week-12, and no grade ≥3 events. Dose modification was only required in one control. Decrease in alpha-diversity and F.prausnitzii were associated with earlier diarrhea onset and longer duration; increase in E.coli correlated with higher grade events. MBR-01 supplementation seemed to preserve microbial diversity and limited E.coli expansion. QoL was significantly improved with MBR-01.

conclusionMBR-01 may effectively mitigate abemaciclib-induced diarrhea, likely through the achievement of stabilization of gut microbiota composition. Larger prospective studies are warranted to validate these preliminary findings.

Indexed as

AminopyridinesBenzimidazolesBreast NeoplasmsDiarrheaPrebioticsProbioticsAgedCase-Control StudiesChemotherapy, AdjuvantFemaleGastrointestinal MicrobiomeHumansLetrozoleMiddle AgedPilot ProjectsPostmenopauseabemaciclibAminopyridinesBenzimidazolesLetrozolePrebioticsAbemaciclibBreast cancerDiarrheaMicrobiomePrebioticsProbiotics

Identifiers

PMID42235180
PMCPMC13254666

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.