Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT01127295
Status:
COMPLETED
Last Update Posted:
2018-03-02
First Post:
2010-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacology of Adjuvant Hormonotherapy in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'C056516', 'term': 'exemestane'}], 'ancestors': [{'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': 'D009570', 'term': 'Nitriles'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-01', 'studyFirstSubmitDate': '2010-05-18', 'studyFirstSubmitQcDate': '2010-05-19', 'lastUpdatePostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between pharmacokinetic and pharmacogenetic parameters', 'timeFrame': '9 years', 'description': 'To estimate the correlations between pharmacokinetic and pharmacogenetic parameters of hormonal adjuvant breast cancer treatment during the first 3 years.'}], 'secondaryOutcomes': [{'measure': 'To estimate the relation between plasmatic concentrations, pharmacogenetic characteristic and adverse effects.', 'timeFrame': '9 years'}, {'measure': 'To estimate the relation between the genetic polymorphisms and premature relapses in the first 3 years of treatment', 'timeFrame': '9 years'}, {'measure': 'To estimate the link between plasmatic concentrations and the premature relapse (in the first 3 years)', 'timeFrame': '9 years'}, {'measure': 'To estimate the declared therapeutic observance to the real exposure at the treatment measured by plasmatic concentrations.', 'timeFrame': '9 years'}, {'measure': 'appearance auto-antibody and correlate to the clinical data', 'timeFrame': '9 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Pharmacogenetic', 'tamoxifen', 'anti-aromatases', 'breast cancer', 'pharmacodynamy', 'Observance'], 'conditions': ['Hormono-depending Adjuvant Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '38788907', 'type': 'DERIVED', 'citation': 'Puszkiel A, Dalenc F, Tafzi N, Marquet P, Debled M, Jacot W, Venat-Bouvet L, Ferrer C, Levasseur N, Paulon R, Dauba J, Evrard A, Mauries V, Filleron T, Chatelut E, Thomas F, White-Koning M. Identification of non-adherence to adjuvant letrozole using a population pharmacokinetics approach in hormone receptor-positive breast cancer patients. Eur J Pharm Sci. 2024 Aug 1;199:106809. doi: 10.1016/j.ejps.2024.106809. Epub 2024 May 22.'}, {'pmid': '33047329', 'type': 'DERIVED', 'citation': 'Puszkiel A, Arellano C, Vachoux C, Evrard A, Le Morvan V, Boyer JC, Robert J, Delmas C, Dalenc F, Debled M, Venat-Bouvet L, Jacot W, Dohollou N, Bernard-Marty C, Laharie-Mineur H, Filleron T, Roche H, Chatelut E, Thomas F, White-Koning M. Model-Based Quantification of Impact of Genetic Polymorphisms and Co-Medications on Pharmacokinetics of Tamoxifen and Six Metabolites in Breast Cancer. Clin Pharmacol Ther. 2021 May;109(5):1244-1255. doi: 10.1002/cpt.2077. Epub 2020 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'This is a biomedical study of interventional type, multicenter, inter-regional.\n\nPatients with hormono-depending breast cancer, for which an indication of adjuvant hormonotherapy treatment (according to the current treatments) was retained, will be enrolled in this study. The main objective is to estimate the correlations between pharmacokinetic and pharmacogenetic parameters of adjuvant hormonal breast cancer treatment, during the first 3 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient of more than 18 years old (menopaused or not)\n2. Invasive breast cancer non-metastatic locally controlled by surgery with or without radiotherapy. Previous treatment with chemotherapy is allowed including trastuzumab\n3. Cancer hormone-expressing ER and / or PR (\\> 10% tumor cells in Technical HIC)\n4. Having a staging exploring bone, liver, lung and showing no abnormality secondary (for sub-centimeter tumors, the staging is not necessary)\n5. WHO \\<2\n6. Before the initiation of adjuvant hormonal therapy (tamoxifen, anastrozole, letrozole or exemestane) and whatever the approach chosen by the investigator (5 years of tamoxifen, 5 years of anti-aromatase or sequential patterns)\n7. signed Consent collected before any specific procedure in the study\n8. Patient member in a national insurance scheme.\n\nExclusion Criteria:\n\n1. Patient previously treated for breast cancer receiving hormonal therapy with tamoxifen, anastrozole, letrozole or exemestane regardless of the scheme\n2. Metastatic Breast cancer\n3. History of another cancer diagnosed within 5 years before or uncontrolled except carcinoma in situ of cervix carcinoma, nonmelanoma skin, breast cancer (in this case, treatment with hormone therapy should be stopped for at least 6 months)\n4. Any other medical or psychiatric condition or laboratory abnormality severe acute or chronic making the inclusion of the patient in the study inappropriate in the opinion of the investigator\n5. Patient unable to follow procedures, visits, examinations described in the study\n6. Pregnant women or nursing mothers can not participate in the study\n7. Women of childbearing age must use effective contraception at study entry and up to at least three months after the end of treatment\n8. Patient under legal guardianship'}, 'identificationModule': {'nctId': 'NCT01127295', 'acronym': 'PHACS', 'briefTitle': 'Pharmacology of Adjuvant Hormonotherapy in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institut Claudius Regaud'}, 'officialTitle': 'Breast Cancer Adjuvant Hormonotherapy : Tamoxifen and the Anti-aromatases Pharmacokinetics, Correlation With the Pharmacogenetic Characteristics PHACS Protocol : Pharmacology of Adjuvant Hormonotherapy in Breast Cancer', 'orgStudyIdInfo': {'id': '09 SEIN 09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Tamoxifen, Anastrozole, letrozole, Exemestane', 'description': 'Current hormonotherapy treatment in hormono dependent breast cancer', 'interventionNames': ['Drug: Tamoxifen, Letrozole, Anastrozole or Exemestane']}], 'interventions': [{'name': 'Tamoxifen, Letrozole, Anastrozole or Exemestane', 'type': 'DRUG', 'description': 'Tamoxifen 20 mg/day during 5 years Létrozole 2.5 mg/day during 5 years Anastrozole 1 mg/day during 5 years Exémestane 25 mg/day during 5 years', 'armGroupLabels': ['Tamoxifen, Anastrozole, letrozole, Exemestane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47000', 'city': 'Agen', 'country': 'France', 'facility': 'Clinique Calabet', 'geoPoint': {'lat': 44.20199, 'lon': 0.62055}}, {'zip': '81030', 'city': 'Albi', 'country': 'France', 'facility': 'Clinique Claude Bernard', 'geoPoint': {'lat': 43.9298, 'lon': 2.148}}, {'zip': '32008', 'city': 'Auch', 'country': 'France', 'facility': "Centre Hospitalier d'Auch", 'geoPoint': {'lat': 43.64561, 'lon': 0.58856}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Clinique Tivoli', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33077', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Polyclinique Bordeaux Nord', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '19312', 'city': 'Brive-la-Gaillarde', 'country': 'France', 'facility': 'Centre Hospitalier de Brive', 'geoPoint': {'lat': 45.1589, 'lon': 1.53326}}, {'zip': '46005', 'city': 'Cahors', 'country': 'France', 'facility': 'Centre Hospitalier de Cahors', 'geoPoint': {'lat': 44.4491, 'lon': 1.43663}}, {'zip': '81108', 'city': 'Castres', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal de Castres-Mazamet', 'geoPoint': {'lat': 43.60527, 'lon': 2.24088}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Hôpital Dupuytren CHU Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '40024', 'city': 'Mont-de-Marsan', 'country': 'France', 'facility': 'Centre Hospitalier de Mont de Marsan', 'geoPoint': {'lat': 43.89022, 'lon': -0.49713}}, {'zip': '82013', 'city': 'Montauban', 'country': 'France', 'facility': 'Centre Hospitalier de Montauban', 'geoPoint': {'lat': 44.01759, 'lon': 1.3542}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "Centre Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Hôpital Caremeau CHU Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '64000', 'city': 'Pau', 'country': 'France', 'facility': 'Centre Hospitalier de Pau', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'zip': '66000', 'city': 'Perpignan', 'country': 'France', 'facility': "Centre Catalan d'Oncologie", 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '12000', 'city': 'Rodez', 'country': 'France', 'facility': 'Centre Hospitalier de Rodez', 'geoPoint': {'lat': 44.35258, 'lon': 2.57338}}, {'zip': '65000', 'city': 'Tarbes', 'country': 'France', 'facility': "Polyclinique de l'Ormeau", 'geoPoint': {'lat': 43.23407, 'lon': 0.07139}}, {'zip': '31052', 'city': 'Toulouse', 'country': 'France', 'facility': 'Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31076', 'city': 'Toulouse', 'country': 'France', 'facility': "Clinique Pasteur - Département d'Oncologie Médicale", 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31300', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur - Département de Radiothérapie', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31400', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Saint-Jean du Languedoc', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Henri ROCHE, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Claudius Regaud'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Claudius Regaud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}