Clinical trial · Interventional
Alcohol and Breast Cancer (ABC) Trial
Effect of Light Alcohol Intake on Sex Hormone Levels Among Postmenopausal Women With ER+ Breast Cancer on Aromatase Inhibitor Therapy: The Alcohol and Breast Cancer (ABC) Trial
NCT05423730CI-TRIAL-00083982completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research study is a pilot study, which is the first time investigators are examining the effect of light alcohol consumption on sex hormones among postmenopausal women with estrogen receptor-positive (ER+) breast cancer taking an aromatase inhibitor The names of the study exposures involved in this study are: * White wine * White grape juice
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aromatase Inhibitors | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| ER+ Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Grape Juice | Other | — | UNRESOLVED |
| White Wine | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- WHITE WINE FOLLOWED BY WHITE GRAPE JUICE
- description
- Participants will be randomized into one of the study drinking sequence groups: white wine followed by white grape juice or white grape juice followed by white wine. The research study procedures include one screening visit to obtain informed consent, four study visits with blood draws, and ten weekly phone calls and online questionnaires over the ten weeks of the study. -3 weeks of daily white wine followed by 3 weeks of daily white grape juice
- interventionNames
- Other: White Wine
- Other: Grape Juice
- type
- EXPERIMENTAL
- label
- WHITE GRAPE JUICE FOLLOWED BY WHITE WINE
- description
- Participants will be randomized into one of the study drinking sequence groups: white grape juice followed by white wine. The research study procedures include one screening visit to obtain informed consent, four study visits with blood draws, and ten weekly phone calls and online questionnaires over the ten weeks of the study. \- 3 weeks of daily white grape juice followed by 3 weeks of daily white wine
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * ER+ breast cancer * Female sex at birth * Postmenopausal, either natural or induced * Self-reported consumption of at least one alcoholic drink per week but not more than one serving per day * Currently prescribed aromatase inhibitors including anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) * Documented liver function test results below 1.5X the upper limit of normal within 12 months of screening Exclusion Criteria: * Self-reported consumption of more than one drink per day, a previous or current history of alcohol abuse based on standard questionnaires (AUDIT≥8), or consumption of more than 4 or more drinks in one day within the last 6 months * Currently undergoing cytotoxic chemotherapy or radiation or planned in the next two months * Any surgery planned in the next two months * Alcohol flushing syndrome * Current use of any pharmaceutical agent contraindicated with alcohol, including warfarin, dual antiplatelet therapy, and metronidazole * Hemoglobin A1c\>8% or a fasting glucose result above 180 mg/dL within 6 months of screening * Unable to speak or understand English * Unable to understand and provide informed consent, as judged by the study team
References
Publications (1)
- DERIVEDMostofsky E, Buring JE, Come SE, Tung NM, Zhang C, Mukamal KJ. Effect of daily alcohol intake on sex hormone levels among postmenopausal breast cancer survivors on aromatase inhibitor therapy: a randomized controlled crossover pilot study. Breast Cancer Res. 2025 Jan 9;27(1):5. doi: 10.1186/s13058-024-01940-4. PMID 39789640