Breath Test for Women Receiving Tamoxifen in the Prevention or Treatment of Breast Cancer

• Status: Terminated
• Trial end date: 2015-09-23
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: A breath test that measures enzymes may be effective in identifying women in whom tamoxifen may not be effective.

PURPOSE: This clinical trial is studying a breath test to see how well it works in women receiving tamoxifen for the prevention or treatment of breast cancer.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dextromethorphan; Tamoxifen

Criteria

DISEASE CHARACTERISTICS:

• Eligible to receive tamoxifen for 6 months for either the prevention or treatment of non-invasive or invasive, stage I-III breast cancer

• CYP2D6 genotype known

• Patients determined to be CYP2D6 poor metabolizers (by determination of a genotype test by their Mayo physician prior to study registration) are eligible to proceed with the initial breath test only

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• ECOG performance status 0-2

• Life expectancy > 6 months

• No known impaired hepatic activity defined as ≥ grade 3 AST, alkaline phosphatase, or total bilirubin

• No pulmonary disease (e.g., asthma or other respiratory disease) associated with hypercapnia

• No uncontrolled metabolic disease (e.g., diabetes in the presence of gastroparesis, uncontrolled congestive heart failure, or uncontrolled gastrointestinal disorders [e.g., GERD])

• No prior adverse reaction to dextromethorphan

• No history of chronic liver disease (e.g., hepatitis B or hepatitis C, alcoholic liver disease, cirrhosis, or fibrotic disease)

• Able and willing to fast overnight prior to the study session

• Willing to return to Mayo Clinic for follow-up

• Willing to provide biologic specimens

PRIOR CONCURRENT THERAPY:

• More than 24 hours since prior medications known to slow gastric emptying or gastrointestinal motility (e.g., alcohol, opioid analgesics, anticholinergics [e.g., antihistamines], and loperamide)

• More than 4 weeks since prior and no concurrent CYP2D6 inhibitors or concurrent serotonin-reuptake inhibitors known to be potent CYP2D6 inhibitors (e.g.,paroxetine [Paxil®] and fluoxetine [Prozac®]

• If mild to moderate inhibitors of CYP2D6 are medically necessary, patients may go back on after the 8-week time point

• More than 4 weeks since prior and no concurrent monoamine-oxidase inhibitors (e.g., furazolidone, phenelzine, procarbazine, selegiline, and tranylcypromine)