Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-01 @ 7:53 PM
Study NCT ID:
NCT00873366
Status:
TERMINATED
Last Update Posted:
2018-01-23
First Post:
2009-03-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Breath Test for Women Receiving Tamoxifen in the Prevention or Treatment of Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003915', 'term': 'Dextromethorphan'}, {'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D002851', 'term': 'Chromatography, High Pressure Liquid'}, {'id': 'D000071185', 'term': 'Pharmacogenomic Testing'}, {'id': 'D061848', 'term': 'Optical Imaging'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002853', 'term': 'Chromatography, Liquid'}, {'id': 'D002845', 'term': 'Chromatography'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'goetz.matthew@mayo.edu', 'phone': '507-284-2511', 'title': 'Dr. Matthew P. Goetz', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 month', 'description': 'All eligible participants with adverse events data reported. Adverse events data were not available on 7 participants.', 'eventGroups': [{'id': 'EG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.', 'otherNumAtRisk': 70, 'otherNumAffected': 2, 'seriousNumAtRisk': 70, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAEV3.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Operating Characteristics of the ¹³C-dextromethorphan (13C-DM) Breath Test in Identifying Those Who Are CYP2D6 Genotypic Poor Metabolizers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'title': 'EM/UM (*1/*2AXN)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'EM/UM (*1/*1XN)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'IM/UM (*41/*2AXN)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'EM/EM (*1/*1)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'EM/EM (*1/*2A)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'EM/EM (*1/*2)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'EM/EM (*2/*2)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'EM/EM (*2A/*2A)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'EM/IM (*1/*9)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'EM/IM (*1/*10)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'EM/IM (*1/*41)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'EM/IM (*2A/*9)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'EM/IM (*2A/*41)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'EM/PM (*1/*3)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'EM/PM (*1/*4)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'EM/PM (*2/*4)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'EM/PM (*2/*4XN)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'EM/PM (*2A/*4)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'EM/PM (*2A/*5)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'EM/PM (*2A/*6)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'IM/IM (*41/*41)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'IM/PM (*3/*41)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'IM/PM (*4/*9)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'IM/PM (*4/*10)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'IM/PM (*4/*41)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'PM/PM (*3/*4)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PM/PM (*4/*4)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Spearman's Rank Correlation Coefficient Between CYP2D6 Genotype and ¹³Cdextromethorphan Breath Test (DM-BT)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 3 month and 6 month', 'description': 'Spearman rank order correlation coefficients were used to assess the strength of the association between CYP2D6 genotype activity score and DM-BT values.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with DM-BT values.'}, {'type': 'SECONDARY', 'title': "Spearman's Rank Correlation Coefficient Between CYP2D6 Activity Score and Endoxifen Steady State Concentrations (Endx Css)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.47', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 Month and 6 Month', 'description': 'Spearman rank order correlation coefficients were used to assess the strength of the association between CYP2D6 genotype activity score and Endx Css', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with Endoxifen pharmacokinetics data.'}, {'type': 'SECONDARY', 'title': "Spearman's Rank Correlation Coefficient Between CYP2D6 Activity Score and Endoxifen/N-desmethyl-tamoxifen (Endx/NDMT) Ratio", 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.60', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 Month and 6 Month', 'description': 'Spearman rank order correlation coefficients were used to assess the strength of the association between CYP2D6 genotype activity score and Endx/NDMT ratio', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with Endoxifen pharmacokinetics data.'}, {'type': 'SECONDARY', 'title': "Spearman's Rank Correlation Coefficient Between Baseline DM-BT and 3 Month Endoxifen Steady State Concentrations", 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 3 month', 'description': 'Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen steady state concentrations (Endx Css)', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with DM-BT values and Endoxifen pharmacokinetics data.'}, {'type': 'SECONDARY', 'title': "Spearman's Rank Correlation Coefficient Between Baseline DM-BT and 3 Month Endoxifen/N-desmethyl-tamoxifen (Endx/NDMT) Ratio", 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 3 month', 'description': 'Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen/N-desmethyl-tamoxifen (Endx/NDMT) Ratio', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with DM-BT values and Endoxifen pharmacokinetics data.'}, {'type': 'SECONDARY', 'title': "Spearman's Rank Correlation Coefficient Between 3 Month DM-BT and 3 Month Endoxifen Steady State Concentrations", 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 month', 'description': 'Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen steady state concentrations (Endx Css)', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with DM-BT values and Endoxifen pharmacokinetics data.'}, {'type': 'SECONDARY', 'title': "Spearman's Rank Correlation Coefficient Between 6 Month DM-BT and 6 Month Endoxifen Steady State Concentrations", 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 month', 'description': 'Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen steady state concentrations (Endx Css)', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with DM-BT values and Endoxifen pharmacokinetics data.'}, {'type': 'SECONDARY', 'title': 'Median of 3 Month Tamoxifen Steady State Plasma Concentrations According to CYP2D6 Phenotype Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'title': 'PM/PM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '219.6', 'groupId': 'OG000', 'lowerLimit': '111.3', 'upperLimit': '327.9'}]}]}, {'title': 'IM/PM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '233.8', 'groupId': 'OG000', 'lowerLimit': '114.8', 'upperLimit': '275.0'}]}]}, {'title': 'IM/IM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '272.3', 'comment': 'Only one participant has the data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'PM/EM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '257.7', 'groupId': 'OG000', 'lowerLimit': '163.0', 'upperLimit': '514.1'}]}]}, {'title': 'EM/IM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '279.1', 'groupId': 'OG000', 'lowerLimit': '135.8', 'upperLimit': '416.5'}]}]}, {'title': 'EM/EM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '201.0', 'groupId': 'OG000', 'lowerLimit': '134.7', 'upperLimit': '401.4'}]}]}, {'title': 'IM/UM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'EM/UM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '313.3', 'comment': 'Only one participant has the data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 3 month Tamoxifen steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.', 'unitOfMeasure': 'nM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with pharmacokinetic data available. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.'}, {'type': 'SECONDARY', 'title': 'Median of 6 Month Tamoxifen Steady State Plasma Concentrations According to CYP2D6 Phenotype Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'title': 'PM/PM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '194.0', 'groupId': 'OG000', 'lowerLimit': '149.3', 'upperLimit': '238.7'}]}]}, {'title': 'IM/PM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '200.5', 'groupId': 'OG000', 'lowerLimit': '117.3', 'upperLimit': '295.6'}]}]}, {'title': 'IM/IM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '279.2', 'comment': 'There is only one participant with the data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'PM/EM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '259.7', 'groupId': 'OG000', 'lowerLimit': '47.2', 'upperLimit': '436.6'}]}]}, {'title': 'EM/IM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '234.7', 'groupId': 'OG000', 'lowerLimit': '128.7', 'upperLimit': '318.6'}]}]}, {'title': 'EM/EM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '179.7', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '460.5'}]}]}, {'title': 'IM/UM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'EM/UM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '301.4', 'groupId': 'OG000', 'lowerLimit': '260.7', 'upperLimit': '342.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 6 month Tamoxifen steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.', 'unitOfMeasure': 'nM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with pharmacokinetic data available. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.'}, {'type': 'SECONDARY', 'title': 'Median of 3 Month N-desmethyl-tamoxifen (NDMT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'title': 'PM/PM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '633.3', 'groupId': 'OG000', 'lowerLimit': '429.0', 'upperLimit': '837.7'}]}]}, {'title': 'IM/PM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '578.0', 'groupId': 'OG000', 'lowerLimit': '387.6', 'upperLimit': '786.2'}]}]}, {'title': 'IM/IM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '691.6', 'comment': 'There is only one participant with the data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'PM/EM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '643.0', 'groupId': 'OG000', 'lowerLimit': '514.6', 'upperLimit': '885.1'}]}]}, {'title': 'EM/IM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '630.7', 'groupId': 'OG000', 'lowerLimit': '362.5', 'upperLimit': '899.8'}]}]}, {'title': 'EM/EM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '457.8', 'groupId': 'OG000', 'lowerLimit': '325.4', 'upperLimit': '766.7'}]}]}, {'title': 'IM/Ultrarapid Metabolism (UM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'EM/UM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '576.9', 'comment': 'There is only one participant with the data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 3 month NDMT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.', 'unitOfMeasure': 'nM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with pharmacokinetic data available. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.'}, {'type': 'SECONDARY', 'title': 'Median of 6 Month N-desmethyl-tamoxifen (NDMT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'title': 'PM/PM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '554.6', 'groupId': 'OG000', 'lowerLimit': '438.5', 'upperLimit': '670.7'}]}]}, {'title': 'IM/PM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '542.4', 'groupId': 'OG000', 'lowerLimit': '296.2', 'upperLimit': '813.6'}]}]}, {'title': 'IM/IM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '718.2', 'comment': 'There is only one participant with the data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'PM/EM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '546.5', 'groupId': 'OG000', 'lowerLimit': '232.7', 'upperLimit': '979.5'}]}]}, {'title': 'EM/IM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '525.9', 'groupId': 'OG000', 'lowerLimit': '373.2', 'upperLimit': '913.8'}]}]}, {'title': 'EM/EM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '401.8', 'groupId': 'OG000', 'lowerLimit': '280.9', 'upperLimit': '867.7'}]}]}, {'title': 'IM/UM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'EM/UM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '552.9', 'groupId': 'OG000', 'lowerLimit': '481.2', 'upperLimit': '624.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 6 month NDMT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.', 'unitOfMeasure': 'nM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with Endoxifen pharmacokinetics data. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.'}, {'type': 'SECONDARY', 'title': 'Median of 3 Month 4-hydroxy-tamoxifen (4HT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'title': 'PM/PM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000', 'lowerLimit': '2.79', 'upperLimit': '3.47'}]}]}, {'title': 'IM/PM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '3.45'}]}]}, {'title': 'IM/IM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.52', 'comment': 'There is only one participant with the data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'PM/EM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.62', 'groupId': 'OG000', 'lowerLimit': '2.08', 'upperLimit': '8.77'}]}]}, {'title': 'EM/IM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.41', 'groupId': 'OG000', 'lowerLimit': '2.75', 'upperLimit': '16.82'}]}]}, {'title': 'EM/EM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.64', 'groupId': 'OG000', 'lowerLimit': '1.38', 'upperLimit': '20.05'}]}]}, {'title': 'IM/UM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'EM/UM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.21', 'comment': 'There is only one participant with the data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 3 month 4HT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.', 'unitOfMeasure': 'nM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with pharmacokinetics data. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.'}, {'type': 'SECONDARY', 'title': 'Median of 6 Month 4-hydroxy-tamoxifen (4HT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'title': 'PM/PM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.17', 'groupId': 'OG000', 'lowerLimit': '2.15', 'upperLimit': '4.19'}]}]}, {'title': 'IM/PM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.37', 'upperLimit': '3.02'}]}]}, {'title': 'IM/IM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'comment': 'There is only one participant with the data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'PM/EM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.81', 'groupId': 'OG000', 'lowerLimit': '1.37', 'upperLimit': '12.07'}]}]}, {'title': 'EM/IM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.86', 'groupId': 'OG000', 'lowerLimit': '2.48', 'upperLimit': '14.10'}]}]}, {'title': 'EM/EM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.96', 'groupId': 'OG000', 'lowerLimit': '1.18', 'upperLimit': '14.1'}]}]}, {'title': 'IM/UM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'EM/UM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.38', 'groupId': 'OG000', 'lowerLimit': '5.24', 'upperLimit': '5.51'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 6 month 4HT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.', 'unitOfMeasure': 'nM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with pharmacokinetic data available. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.'}, {'type': 'SECONDARY', 'title': 'Median of 3 Month Endoxifen Steady State Concentrations (Endx Css) According to CYP2D6 Phenotype Group and Activity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'title': 'EM/UM (3.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.6', 'comment': 'There is only one participant with the data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'IM/UM (2.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'EM/EM (2.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '74.3'}]}]}, {'title': 'EM/IM (1.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '44.7'}]}]}, {'title': 'IM/IM (1.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.5', 'comment': 'There is only one participant with the data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'EM/PM (1.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '50.9'}]}]}, {'title': 'IM/PM (0.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '8.5'}]}]}, {'title': 'PM/PM (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '6.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 3 month Endx Css for each CYP2D6 phenotype group and the corresponding activity score are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.', 'unitOfMeasure': 'nM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with Endoxifen pharmacokinetics data. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.'}, {'type': 'SECONDARY', 'title': 'Median of 6 Month Endoxifen Steady State Concentrations (Endx Css) According to CYP2D6 Phenotype Group and Activity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'classes': [{'title': 'EM/UM (3.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '23.1', 'upperLimit': '53.9'}]}]}, {'title': 'IM/UM (2.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'EM/EM (2.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '72.9'}]}]}, {'title': 'EM/IM (1.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '38.3'}]}]}, {'title': 'IM/IM (1.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.3', 'comment': 'There is only one participant with the data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'EM/PM (1.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '53.2'}]}]}, {'title': 'IM/PM (0.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '12.0'}]}]}, {'title': 'PM/PM (0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '7.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 6 month Endx Css for each CYP2D6 phenotype group and the corresponding activity score are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.', 'unitOfMeasure': 'nM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants with Endoxifen pharmacokinetics data. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Off tamoxifen for reconstructive surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Off tamoxifen due to side effects', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Refused to continue DM-BT testing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Ninety one women and one man were enrolled between May 2009 and September 2011.', 'preAssignmentDetails': 'Six women withdrew consent prior to the start of testing. Another 9 participants were excluded from the analysis cohort due to: non-adherence to tamoxifen (N=2), use of a CYP2D6 inhibitor (N=1) and lack of sufficient samples for ¹³Cdextromethorphan analysis (N=6).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '¹³C-DM-BT', 'description': 'Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'categories': [{'title': '0=Asymptomatic and fully active', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}, {'title': '1=Symptomatic and fully ambulatory', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'groupId': 'BG000', 'lowerLimit': '18.9', 'upperLimit': '47.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Disease Status', 'classes': [{'categories': [{'title': 'Noninvasive Breast Cancer (DCIS)', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Invasive Breast Cancer in Adjuvant', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}, {'title': 'Invasive Breast Cancer in Metastatic', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Funding issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2009-03-31', 'resultsFirstSubmitDate': '2017-10-12', 'studyFirstSubmitQcDate': '2009-03-31', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-22', 'studyFirstPostDateStruct': {'date': '2009-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operating Characteristics of the ¹³C-dextromethorphan (13C-DM) Breath Test in Identifying Those Who Are CYP2D6 Genotypic Poor Metabolizers', 'timeFrame': 'Baseline', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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.'}], 'secondaryOutcomes': [{'measure': "Spearman's Rank Correlation Coefficient Between CYP2D6 Genotype and ¹³Cdextromethorphan Breath Test (DM-BT)", 'timeFrame': 'Baseline, 3 month and 6 month', 'description': 'Spearman rank order correlation coefficients were used to assess the strength of the association between CYP2D6 genotype activity score and DM-BT values.'}, {'measure': "Spearman's Rank Correlation Coefficient Between CYP2D6 Activity Score and Endoxifen Steady State Concentrations (Endx Css)", 'timeFrame': '3 Month and 6 Month', 'description': 'Spearman rank order correlation coefficients were used to assess the strength of the association between CYP2D6 genotype activity score and Endx Css'}, {'measure': "Spearman's Rank Correlation Coefficient Between CYP2D6 Activity Score and Endoxifen/N-desmethyl-tamoxifen (Endx/NDMT) Ratio", 'timeFrame': '3 Month and 6 Month', 'description': 'Spearman rank order correlation coefficients were used to assess the strength of the association between CYP2D6 genotype activity score and Endx/NDMT ratio'}, {'measure': "Spearman's Rank Correlation Coefficient Between Baseline DM-BT and 3 Month Endoxifen Steady State Concentrations", 'timeFrame': 'Baseline, 3 month', 'description': 'Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen steady state concentrations (Endx Css)'}, {'measure': "Spearman's Rank Correlation Coefficient Between Baseline DM-BT and 3 Month Endoxifen/N-desmethyl-tamoxifen (Endx/NDMT) Ratio", 'timeFrame': 'Baseline, 3 month', 'description': 'Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen/N-desmethyl-tamoxifen (Endx/NDMT) Ratio'}, {'measure': "Spearman's Rank Correlation Coefficient Between 3 Month DM-BT and 3 Month Endoxifen Steady State Concentrations", 'timeFrame': '3 month', 'description': 'Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen steady state concentrations (Endx Css)'}, {'measure': "Spearman's Rank Correlation Coefficient Between 6 Month DM-BT and 6 Month Endoxifen Steady State Concentrations", 'timeFrame': '6 month', 'description': 'Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen steady state concentrations (Endx Css)'}, {'measure': 'Median of 3 Month Tamoxifen Steady State Plasma Concentrations According to CYP2D6 Phenotype Group', 'timeFrame': '3 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 3 month Tamoxifen steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.'}, {'measure': 'Median of 6 Month Tamoxifen Steady State Plasma Concentrations According to CYP2D6 Phenotype Group', 'timeFrame': '6 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 6 month Tamoxifen steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.'}, {'measure': 'Median of 3 Month N-desmethyl-tamoxifen (NDMT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group', 'timeFrame': '3 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 3 month NDMT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.'}, {'measure': 'Median of 6 Month N-desmethyl-tamoxifen (NDMT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group', 'timeFrame': '6 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 6 month NDMT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.'}, {'measure': 'Median of 3 Month 4-hydroxy-tamoxifen (4HT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group', 'timeFrame': '3 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 3 month 4HT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.'}, {'measure': 'Median of 6 Month 4-hydroxy-tamoxifen (4HT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group', 'timeFrame': '6 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 6 month 4HT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.'}, {'measure': 'Median of 3 Month Endoxifen Steady State Concentrations (Endx Css) According to CYP2D6 Phenotype Group and Activity Score', 'timeFrame': '3 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 3 month Endx Css for each CYP2D6 phenotype group and the corresponding activity score are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.'}, {'measure': 'Median of 6 Month Endoxifen Steady State Concentrations (Endx Css) According to CYP2D6 Phenotype Group and Activity Score', 'timeFrame': '6 Month', 'description': 'Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.\n\nThe specific phenotype, alleles and their associated activity score (AS) assessed were as follows:\n\nUltrarapid 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 median of 6 month Endx Css for each CYP2D6 phenotype group and the corresponding activity score are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: A breath test that measures enzymes may be effective in identifying women in whom tamoxifen may not be effective.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\n* 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 metabolizers.\n* To examine the correlation between CYP2D6 enzyme activity (as measured by the breath test) and plasma endoxifen (and 4-hydroxyTAM) levels in patients who carry one or more CYP2D6 functional alleles.\n* To examine the change in CYP2D6 enzyme activity (as measured by the ¹³C-DM breath test), in patients who start a CYP2D6 inhibitor while taking tamoxifen.\n* To determine whether CYP2D6 enzyme activity (as measured by the breath test) changes over time (either as a consequence of drug-induced inhibition or other).\n* To measure genetic variation in additional genes that are later identified to affect the metabolism, uptake, or distribution of tamoxifen (e.g., SULT1A1, UGT).\n\nOUTLINE: Patients receive tamoxifen citrate for 6 months. \\^13C-dextromethorphan breath tests are conducted at baseline and periodically during the 6 months.\n\n13C-dextromethorphan breath test: Patients receive oral Alka-Seltzer® Gold (ASG; citric acid, potassium bicarbonate, and sodium bicarbonate) in water, then, 15 minutes later, another ASG dose and oral ¹³C-dextromethorphan. Patients breathe into a bag 1-2 times, and the is bag sealed. ¹³CO\\_2 levels in the bags are measured.\n\nBlood samples are collected at baseline and periodically for pharmacogenetic and pharmacokinetic studies by reverse phase HPLC with fluorescence detection.\n\nAfter completion of study therapy, patients are followed annually for 5 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female breast cancer', 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Eligible to receive tamoxifen for 6 months for either the prevention or treatment of non-invasive or invasive, stage I-III breast cancer\n* CYP2D6 genotype known\n\n * 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\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Menopausal status not specified\n* ECOG performance status 0-2\n* Life expectancy \\> 6 months\n* No known impaired hepatic activity defined as ≥ grade 3 AST, alkaline phosphatase, or total bilirubin\n* No pulmonary disease (e.g., asthma or other respiratory disease) associated with hypercapnia\n* No uncontrolled metabolic disease (e.g., diabetes in the presence of gastroparesis, uncontrolled congestive heart failure, or uncontrolled gastrointestinal disorders \\[e.g., GERD\\])\n* No prior adverse reaction to dextromethorphan\n* No history of chronic liver disease (e.g., hepatitis B or hepatitis C, alcoholic liver disease, cirrhosis, or fibrotic disease)\n* Able and willing to fast overnight prior to the study session\n* Willing to return to Mayo Clinic for follow-up\n* Willing to provide biologic specimens\n\nPRIOR CONCURRENT THERAPY:\n\n* 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)\n* 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®\\]\n\n * If mild to moderate inhibitors of CYP2D6 are medically necessary, patients may go back on after the 8-week time point\n* More than 4 weeks since prior and no concurrent monoamine-oxidase inhibitors (e.g., furazolidone, phenelzine, procarbazine, selegiline, and tranylcypromine)'}, 'identificationModule': {'nctId': 'NCT00873366', 'briefTitle': 'Breath Test for Women Receiving Tamoxifen in the Prevention or Treatment of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': '¹³C - Dextromethorphan (DM) Breath Test for Determination of CYP2D6 Enzyme Activity in Patients Receiving Tamoxifen', 'orgStudyIdInfo': {'id': 'MC083C'}, 'secondaryIdInfos': [{'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}, {'id': 'MC083C', 'type': 'OTHER', 'domain': 'Mayo Clinic Cancer Center'}, {'id': '08-007073', 'type': 'OTHER', 'domain': 'Mayo Clinic IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'dextromethorphan hydrobromide', 'type': 'DRUG'}, {'name': 'tamoxifen citrate', 'type': 'DRUG'}, {'name': 'high performance liquid chromatography', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'pharmacogenomic studies', 'type': 'OTHER'}, {'name': 'pharmacological study', 'type': 'OTHER'}, {'name': 'fluorescence imaging', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Matthew P. Goetz, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}, {'name': 'Donald W. Northfelt, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}