NIH-funded research R01 grant

Gut microbes and the early spread of hormone-receptor–positive breast cancer

Official title: Gut microbiome-mediated differences within the pre-malignant mammary tissue environment enhance early breast tumor metastasis

Funded at University of Virginia · NIH-11262931 · Data updated 2026-11-12

This project looks at whether changes in gut bacteria help hormone-receptor–positive (HR+) breast cancer spread early in people with HR+ tumors.

More Metastasis research and trials

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionUniversity of Virginia
NIH-funded
Lab location1 site (Charlottesville, United States)
Project startMarch 1, 2023
Project endFebruary 29, 2028
Funding year2026
Award (this year)$447,799
NIH project number5R01CA262634-04
Project IDNIH-11262931 on NIH RePORTER

Who could benefit from this research

Could help

People with hormone-receptor–positive (ER+/PR+, HER2−) breast cancer, especially those interested in research about factors that influence early metastatic spread or willing to provide stool or tissue samples, would be most relevant.

Less likely to help

People with other breast cancer subtypes (HER2-positive or triple-negative) or those with widespread metastatic disease may not directly benefit from findings focused on HR+ early spread.

What this research studies

The research team is studying how an imbalanced gut microbiome might change the normal breast tissue and make it easier for HR+ cancer cells to leave the breast and travel to other organs. They will use laboratory and animal models to follow tumor cell spread and to study cells and signals in the breast tissue that change when the microbiome is altered. The team will focus on immune cells called mast cells and related molecular pathways that may be triggered by microbiome changes. Findings may also guide testing of microbiome- or immune-targeted approaches to lower the risk of early spread.

Why it matters

Potential benefit: If successful, this work could point to new ways to prevent or reduce early metastatic spread in people with HR+ breast cancer by targeting the gut microbiome or tissue immune responses.

How similar studies have gone: Animal studies, including the investigators' prior work, show gut microbiome imbalance can promote tumor cell dissemination, but translating microbiome-targeted prevention to people is still new and largely unproven.

Where this research is happening

  • University of Virginia
    Charlottesville, United States
    Active

Researchers

  • Principal investigator: Rutkowski, Melanie R — University of Virginia
  • Study coordinator: Rutkowski, Melanie R

Related research

Other NIH-funded projects on the same topics.

  • How gut bacteria affect breast cancer spread

    This study is looking at how differences in gut bacteria might affect the spread of breast cancer in women with hormone receptor-positive tumors, to help understand why some patients have more aggressive disease than others, even with the same treatment.

    NIH research University of Virginia · Charlottesville, United States · NIH-11015080

  • Understanding how gut bacteria and immune responses affect cancer spread

    This study is looking at how certain gut bacteria and immune system antibodies might affect cancer spread in older adults, and it hopes to find ways to improve cancer treatment by understanding these connections better, so patients may be asked to share samples or information to help with the research.

    NIH research Weill Medical Coll of Cornell Univ · New York, United States · NIH-10758543

  • Lymph node metastasis and immune tolerance in head and neck cancer

    A study in people with head and neck cancer looks at how cancer spread to lymph nodes may shape the immune system and help tumors grow.

    NIH research Stanford University · Stanford, United States · NIH-11614785

  • Targeting how RMS cells fail to mature to slow or stop pediatric muscle cancer spread

    A project to understand why a pediatric muscle cancer called rhabdomyosarcoma spreads, and to test ideas that could slow or stop it by helping cancer cells mature properly.

    NIH research Purdue University · West Lafayette, United States · NIH-11609892

  • Multi-agent AI to annotate enzymes in the human gut microbiome

    A team at a major university will build an AI system that automatically curates and labels the functions of enzymes in the human gut microbiome to speed up understanding their health effects.

    NIH research University of South Florida · Tampa, United States · NIH-11594384

  • Mapping how gut bacteria transform drugs

    Scientists will study how the gut microbiome changes thousands of drugs into new forms, which could affect how well a medicine works or whether it causes side effects.

    NIH research Stanford University · Stanford, United States · NIH-11550022

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.