Light Alcohol Intake on Sex Hormone Levels among Women after Menopause on Aromatase Inhibitor Therapy with ER+ Breast Cancer, ABC Trial

Status: closed to accrual

This clinical trial investigates the effect of light alcohol consumption on sex hormones among post-menopausal women with estrogen receptor-positive (ER+) breast cancer taking aromatase inhibitors. Aromatase inhibitors prevent the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy for postmenopausal women who have hormone-dependent breast cancer. Alcohol intake raises sex hormone levels, however, it is unknown if that effect persists in postmenopausal women with ER+ breast cancer taking an aromatase inhibitor. This study may help doctors learn information that could help postmenopausal women with ER+ breast cancer make informed decisions about their alcohol intake.

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 two servings per day
Currently prescribed aromatase inhibitors including anastrozole (Arimidex),letrozole (Femara), and exemestane (Aromasin)
Documented liver function test results below 1.5 X the upper limit of normal within 12 months of screening

Exclusion Criteria

Self-reported consumption of more than two drinks per day, a previous or current history of alcohol abuse based on standard questionnaires ([Alcohol Use Disorders Identification Test] 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
Uncertain ability to complete the protocol, as judged by the study team

PRIMARY OBJECTIVE:

I. To assess whether alcohol at low “real-world” levels of intake increases sex hormone levels in the presence of aromatase inhibitors (AI’s).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients consume white wine once daily (QD) on days 15-35 and white grape juice QD on days 51-71. Patients also undergo collection of blood samples at days 15, 36, 50, and 72.

ARM II: Patients consume white grape juice QD on days 15-35 and white wine QD on days 51-71. Patients also undergo collection of blood samples at days 15, 36, 50, and 72.

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Light Alcohol Intake on Sex Hormone Levels among Women after Menopause on Aromatase Inhibitor Therapy with ER+ Breast Cancer, ABC Trial

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