Status:
TERMINATED
Breath Test for Women Receiving Tamoxifen in the Prevention or Treatment of Breast Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-120 years
Brief 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 ...
Detailed Description
OBJECTIVES: * To assess the operating characteristics of the ¹³C-dextromethorphan (\^13 C-DM) breath test in identifying women with breast cancer (or at high risk) who are CYP2D6-genotypic poor metab...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 23 2015
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00873366
Start Date
May 1 2009
End Date
September 23 2015
Last Update
January 23 2018
Active Locations (2)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
2
Mayo Clinic
Rochester, Minnesota, United States, 55905