Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-29 @ 9:43 PM
Study NCT ID:
NCT01553903
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2011-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not
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': 'C056516', 'term': 'exemestane'}, {'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'D000077289', 'term': 'Letrozole'}], '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-03', 'studyFirstSubmitDate': '2011-12-20', 'studyFirstSubmitQcDate': '2012-03-12', 'lastUpdatePostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of Oxysterols (OCDO, CT and CE)plasma concentrations by Gaz Chromatography coupled to mass spectrometry (GC/MS)in human.', 'timeFrame': '2 time points (D0 and D28) over a period of 2 years', 'description': 'Oxysterols measured are the following : OCDO (6-oxo-cholestan-3 beta, 5 alpha-diol), CE (cholesterol-5,6-eposides) and CT (cholestane-3 beta, 5 alpha, 6 beta-triol).\n\nCalibration curve will be established for each Oxysterol by GC/MS using deuterated analogues of each oxysterols for the quantification.'}], 'secondaryOutcomes': [{'measure': 'Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with Tamoxifen', 'timeFrame': '2 time points (D0 and D28) over a period of 2 years', 'description': 'Plasma concentrations of Oxysterols evaluated by Gaz chromatography coupled to mass spectrometry (GC/MS)in patients after 28 days of hormonal therapy with Tamoxifen in order to determine the impact of the treatment on these plasmatic concentrations(D28 oxysterols plasma concentrations will be compared to D0 oxysterols plasma concentrations)'}, {'measure': 'Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with anti-aromatase.', 'timeFrame': '2 time points (D0 and D28) over a period of 2 years', 'description': 'Plasma concentrations of Oxysterols evaluated by Gaz chromatography coupled to mass spectrometry (GC/MS)in patients after 28 days of hormonal therapy with anti-aromatase (Anastrozole, Letrozole or Exemestane) in order to determine the absence of impact of the treatment on these plasmatic concentrations (D28 oxysterols plasma concentrations will be compared to D0 oxysterols plasma concentrations).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hormonal therapy', 'Breast Cancer', 'AEBS', 'Oxysterols'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a biomedical study of interventional type which includes 29 patients on 9 months: 8 months recruiting and 1 month follow up.\n\nPatients with hormone dependent breast cancer metastatic or non-metastatic, for which an indication of hormonal therapy treatment (with tamoxifen or anti-aromatase) is retained, will be enrolled in this study.\n\nThe main objective of this study is to evaluate the feasibility for the determination of Oxysterols (CT, CE, OCDO) in this patient population, before and after the initiation of treatment (ie, at D0 before and D28 after beginning of treatment).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women of more than 18 years old (menopause or not).\n2. Women with invasive breast cancer metastatic or non-metastatic, for which treatment with tamoxifen or anti-aromatase is retained.\n3. Cancer hormone-expressing estrogen receptor (ER) and / or progesterone receptor (PR) (≥ 10% of tumor cells in Technical HIC).\n4. Any previous hormonal therapy, stopped for progression, should be discontinued for at least 21 days prior to study entry.\n5. WHO ≤ 2.\n6. Women of childbearing age must use effective contraception for the duration of the study.\n7. Informed consent obtained and signed before any specific procedure in the study.\n8. Patient member in a national insurance scheme.\n\nExclusion Criteria:\n\n1. Patient with breast cancer HER2 positive (IHC and / or FISH-CISH)\n2. Patient already receiving hormonal therapy or patient who has not stopped hormonal therapy for at least 21 days.\n3. Patient that should receive a chemotherapy and / or another targeted therapy (other than hormonal therapy) for the treatment of the breast cancer.\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. Patients under legal guardianship.'}, 'identificationModule': {'nctId': 'NCT01553903', 'acronym': 'OXYTAM', 'briefTitle': 'Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not', 'organization': {'class': 'OTHER', 'fullName': 'Institut Claudius Regaud'}, 'officialTitle': 'Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not', 'orgStudyIdInfo': {'id': '11 SEIN 09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tamoxifen,', 'description': 'Current hormonotherapy treatment in hormone dependent breast cancer', 'interventionNames': ['Drug: Tamoxifen,']}, {'type': 'EXPERIMENTAL', 'label': 'Exemestane', 'description': 'Current hormonotherapy treatment in hormone dependent breast cancer', 'interventionNames': ['Drug: Exemestane']}, {'type': 'EXPERIMENTAL', 'label': 'Anastrozole', 'description': 'Current hormonotherapy treatment in hormone dependent breast cancer', 'interventionNames': ['Drug: Anastrozole']}, {'type': 'EXPERIMENTAL', 'label': 'Letrozole', 'description': 'Current hormonotherapy treatment in hormone dependent breast cancer', 'interventionNames': ['Drug: Letrozole']}], 'interventions': [{'name': 'Tamoxifen,', 'type': 'DRUG', 'description': 'Tamoxifen 20 mg/day during 5 years,', 'armGroupLabels': ['Tamoxifen,']}, {'name': 'Exemestane', 'type': 'DRUG', 'description': 'Exemestane 25mg/day during 5 years', 'armGroupLabels': ['Exemestane']}, {'name': 'Anastrozole', 'type': 'DRUG', 'description': 'Anastrozole 1 mg/day during 5 years,', 'armGroupLabels': ['Anastrozole']}, {'name': 'Letrozole', 'type': 'DRUG', 'description': 'Letrozole 2.5 mg/day during 5 years,', 'armGroupLabels': ['Letrozole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31052', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius REGAUD', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Florence DALENC, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Claudius Regaud'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Claudius Regaud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}