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

NCT00873366 | Terminated Results DMC

• 3 other identifiers: MC083CP30CA01508308-007073
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 2

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 works in women receiving tamoxifen for the prevention or treatment of breast cancer.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

• Operating Characteristics of the ¹³C-dextromethorphan (13C-DM) Breath Test in Identifying Those Who Are CYP2D6 Genotypic Poor Metabolizers

  Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system. The specific phenotype, alleles and their associated activity score (AS) assessed were as follows: Ultrarapid metabolism (UM) or AS=2.0 (\*1XN or \*2XN), Extensive metabolism (EM) or AS=1.0 (\*1, \*2, and \*2A), Intermediate metabolism (IM) or AS=0.5 (\*9, \*10, \*17 and \*41), and Poor metabolism (PM) or AS=0.0 (3, \*4, \*5, \*7, \*8, \*11, and \*12). The distribution of CYP2D6 genotypes grouped by CYP2D6 metabolism phenotype for each participants are summarized below.

  Baseline

Secondary Outcomes (15)

• Spearman's Rank Correlation Coefficient Between CYP2D6 Genotype and ¹³Cdextromethorphan Breath Test (DM-BT)

  Baseline, 3 month and 6 month

• Spearman's Rank Correlation Coefficient Between CYP2D6 Activity Score and Endoxifen Steady State Concentrations (Endx Css)

  3 Month and 6 Month

• Spearman's Rank Correlation Coefficient Between CYP2D6 Activity Score and Endoxifen/N-desmethyl-tamoxifen (Endx/NDMT) Ratio

  3 Month and 6 Month

• Spearman's Rank Correlation Coefficient Between Baseline DM-BT and 3 Month Endoxifen Steady State Concentrations

  Baseline, 3 month

• Spearman's Rank Correlation Coefficient Between Baseline DM-BT and 3 Month Endoxifen/N-desmethyl-tamoxifen (Endx/NDMT) Ratio

  Baseline, 3 month

Interventions

dextromethorphan hydrobromide DRUG

tamoxifen citrate DRUG

high performance liquid chromatography OTHER

laboratory biomarker analysis OTHER

pharmacogenomic studies OTHER

pharmacological study OTHER

fluorescence imaging PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female breast cancer

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dextromethorphan; Tamoxifen; Chromatography, High Pressure Liquid; Pharmacogenomic Testing; Optical Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chromatography, Liquid; Chromatography; Chemistry Techniques, Analytical; Investigative Techniques; Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Diagnostic Imaging

Results Point of Contact

• Title: Dr. Matthew P. Goetz
• Organization: Mayo Clinic

goetz.matthew@mayo.edu

507-284-2511

Study Officials

• Matthew P. Goetz, M.D.

  Mayo Clinic

  STUDY CHAIR

• Donald W. Northfelt, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 1, 2009
• Study Start: May 1, 2009
• Primary Completion: September 23, 2015
• Study Completion: September 23, 2015
• Last Updated: January 23, 2018
• Results First Posted: January 23, 2018

Record last verified: 2017-05

Locations

US (2)