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Recruiting

NCT Number: NCT07779967

Alcohol, Breast Cancer, and Metabolism

Alcohol consumption, even at low levels, has been associated with increased breast cancer risk, but the biological mechanisms underlying this relationship remain unclear. This study will examine whether breast tissue may locally metabolize alcohol by measuring alcohol-related compounds in paired blood and breast milk samples from lactating women. The findings may help clarify alcohol-related biological pathways relevant to breast cancer risk and improve risk communication.

Recruiting

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Key information

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Alcohol consumption has been associated with an increased risk of female breast cancer, including at low levels of intake. The biological mechanisms underlying this association are not fully understood. One proposed pathway involves the metabolism of alcohol to alcohol-related compounds that may affect tissue biology.

This study will examine alcohol metabolism in lactating women using paired blood and breast milk samples collected after low-level alcohol exposure. Human milk provides a non-invasive way to study biological processes occurring in the breast during lactation. By comparing alcohol-related measurements in milk and blood, and by considering the timing of sample collection relative to alcohol intake and breast pumping, the study will evaluate whether breast milk measurements provide information about local alcohol metabolism in the mammary gland that may not be reflected by blood measurements alone.

The goal of this research is to improve understanding of how low-level alcohol exposure may influence biological pathways relevant to breast cancer risk. Findings from this study may help inform future research and support clearer risk communication regarding alcohol consumption and breast health.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All aims

-Drink alcohol (at least one alcoholic drink during lactation of a lactating female)

For aims 1 and 2

  • Nursing a 2- to 5-month-old infant
  • Experienced with a breast pump

Exclusion criteria

  • Pregnant
  • Lifetime history of alcohol dependence
  • Drink more than 3 standard drinks per day or more than 7 standard drinks per week in the month previous to enrollment
  • Current regular use of drugs with addiction potential (other than alcohol)
  • Use of medications known to interact with alcohol metabolism
  • Current smoking
  • Anemia
  • Diabetes
  • Liver disease

Treatment and study plan

Low-alcohol level exposure

Other

Participants will consume a protocol-specified low-level alcohol exposure under study conditions. The assigned dose and biospecimen collection procedures will vary by study group.

Breast-pumping time

Other

Breast pumping before or after drinking ~ 1 standard drink or placebo drink

Primary outcomes

  1. Blood alcohol concentrations

    Time frame: 2- 3 weeks

    Alcohol concentrations in blood

  2. Milk alcohol concentration

    Time frame: 2- 3 weeks

    Concentration of alcohol in breast milk

  3. Milk acetaldehyde

    Time frame: 1-3 weeks

    Concentration of acetaldehyde in human milk

  4. Blood acetaldehyde

    Time frame: 1- 3 weeks

    Concentration of acetaldehyde in blood

Study contacts

Contact information is provided by the study sponsor or research team.

Marta Y Pepino de Gruev, Ph D

CONTACT

[email protected]

217-300-2374

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Official study title

Localized Mammary Alcohol Metabolism as a Mechanism Linking Low-Level Alcohol Intake to Breast Cancer Risk

Acronym: ABC-Met

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Aug 21, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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