N/A
N=20
Alcohol and Breast Cancer (ABC) Trial
ER+ Breast Cancer · Breast Cancer · Aromatase Inhibitors
Bottom Line
View on ClinicalTrials.gov: NCT05423730 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Blood Levels of Total Estradiol Concentration — -0.50; -0.39 Log scale, pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- White Wine (Other); Grape Juice (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Levels of Total Estradiol Concentration |
-0.50; -0.39 | — |
| SECONDARY Blood Levels of Free Estradiol Concentration |
-4.53; -4.45 | — |
| SECONDARY Blood Levels of Free Estradiol Index |
-0.01; 0 | — |
| SECONDARY Blood Levels of Estrone Concentration |
0.03; -0.10 | — |
| SECONDARY Blood Levels of Dehydroepiandrosterone Sulfate (DHEAS) |
4.18; 4.08 | — |
| SECONDARY Blood Levels of Testosterone |
2.75; 2.63 | — |
| SECONDARY Blood Levels of Sex Hormone Binding Globulin (SHBG) |
3.87; 3.90 | — |
Summary
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05423730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.