Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT06185569
Status:
RECRUITING
Last Update Posted:
2023-12-29
First Post:
2023-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FREDO-ODX Study: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2023-10-16', 'studyFirstSubmitQcDate': '2023-12-14', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate the clinical outcomes represented by iDFS in French early breast cancer patients with Oncotype DX (ODX) Breast Recurrence Score® (RS) results-guided therapy', 'timeFrame': 'time between surgery and recurrence (local, regional, distant), contralateral breast cancer, second cancer or death (all causes), whichever occurs first, assessed up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Breast cancer-specific survival', 'timeFrame': 'time between surgery and death related to breast cancer, assessed up to 5 years'}, {'measure': 'Distant disease-free survival', 'timeFrame': 'time between surgery and distant recurrence or death (all causes), whichever occurs first, assessed up to 5 years'}, {'measure': 'Locoregional relapse-free survival', 'timeFrame': 'time between surgery and progression/recurrence (local, regional), ipsilateral DCIS or death (all causes), whichever occurs first, assessed up to 5 years'}, {'measure': 'Overall Survival', 'timeFrame': 'time between surgery and death, assessed up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Early breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the clinical outcomes in real-life setting of early breast cancer RH+ HER2- patients with systemic therapy guided by Oncotype DX (ODX) Breast Recurrence Score®.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients ≥ 18 years old, with invasive breast carcinoma diagnosed on biopsy or surgical sample (histological evidence), Operable breast cancer HR+ (at least ER+) /HER2- tumors with ODX assay performed', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years old With invasive breast carcinoma diagnosed on biopsy or surgical sample (histological evidence) Operable breast cancer HR+ (at least ER+) /HER2- tumors With ODX assay performed\n\nExclusion Criteria:\n\n* Inoperable tumor(s) or inoperable patient (e.g., patient too frail to undergo surgery) Synchronous breast cancers with different clinico-pathological features (e.g. : HR+/HER2 negative and triple-negative or HER2-positive breast cancer Patient undergoing neoadjuvant chemotherapy or neoadjuvant hormone therapy Nodal involvement in more than 4 lymph nodes (pN2 or higher) Metastatic breast cancer at diagnosis Other malignancy diagnosed in the past 10 years (except for cutaneous malignancies other than melanoma) The patient participated in the RxPONDER study in France The patient communicated a refusal to participate in the study (via a refusal letter to the investigator) Legal incapacity or limited legal capacity'}, 'identificationModule': {'nctId': 'NCT06185569', 'acronym': 'FREDO-ODX-23', 'briefTitle': 'FREDO-ODX Study: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy', 'orgStudyIdInfo': {'id': '2023/804'}}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elsa CURTIT, MD', 'role': 'CONTACT'}], 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33000', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Delphine GARBAY, MD', 'role': 'CONTACT'}], 'facility': 'Clinique Tivoli Ducos', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33300', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nadine DOHOLLOU, MD', 'role': 'CONTACT'}], 'facility': 'Polyclinique Bordeaux Nord Aquitaine', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '75610', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc-Antoine BENDERRA, MD', 'role': 'CONTACT'}], 'facility': 'AP-HP - Hôpital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '66000', 'city': 'Perpignan', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas LEDUC, MD', 'role': 'CONTACT'}], 'facility': "Centre Catalan d'Oncologie", 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}], 'centralContacts': [{'name': 'Elise ROBERT', 'role': 'CONTACT', 'email': 'e1robert@chu-besancon.fr', 'phone': '+33381219086'}, {'name': 'Diane BERTHOD', 'role': 'CONTACT', 'email': 'dberthod@chu-besancon.fr', 'phone': '+33370632403'}], 'overallOfficials': [{'name': 'Elsa CURTIT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Besancon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}