Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 3:57 PM
Study NCT ID:
NCT06500494
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2024-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Describe How Well Vinorelbine Given Orally Works in Patients With a Breast Cancer After 2 Years of Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 368}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2024-07-08', 'studyFirstSubmitQcDate': '2024-07-12', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS rate in both cohorts.', 'timeFrame': '2-years follow-up', 'description': 'PFS is defined as the time between vinorelbine-based treatment initiation and the first occurrence of progression or death from any cause, with censoring of patients who are lost to follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study looks at how well oral vinorelbine works in treating advanced breast cancer. It looks at women who have already had this treatment or are currently having it.', 'detailedDescription': 'This is an international, multicenter, retrospective and prospective, observational study.\n\nThe study will comprise of two cohorts:\n\n* Retrospective: Patients who started OV treatment for ABC between 2011 and 2020 will be enrolled in the retrospective cohort study. The observation period for retrospectively included patients will extend from the initiation of OV treatment to the date of death, date of last contact or end date of retrospective observation period, whichever occurs first. The end date of retrospective observation period will be set as the date of the inclusion of the first patient in the study (First Patient In= FPI).\n* Prospective: Patients initiating OV treatment and eligible for prospective collection of QoL data and PPQ and WPAI questionnaires will be enrolled in the prospective cohort study. The enrollment period is expected to extend up to 17 months from study start. The study observation period will extend up to 2 years after last patient first visit (around 24 months after treatment initiation).\n\nDue to the observational nature of this study, no additional medical procedures or in person clinical visits beyond routine oncology care will be required for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include advanced breast cancer (ABC) patients treated with Oral Vinorelbine in any line of treatment and living in one of the target countries (Italy, China and Algeria).\n\nABC includes locally advanced breast cancer and metastatic breast cancer either newly diagnosed or a relapse.\n\nThe retrospective cohort will include 130 patients who initiated oral vinorelbine-based therapy (OV) in any line of treatment between 2011 and 2020, whether they are alive, have progressed or have died by the time of data collection.\n\nThe prospective cohort will include 238 patients for whom it is planned, at the time of study enrollment, to receive oral vinorelbine in any line of treatment.', 'genderDescription': 'Female only', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFemale aged ≥ 18 years (≥ 19 years for Algeria as per local regulation) at oral vinorelbine ( OV) -based treatment initiation\n\nConfirmed diagnosis of locally advanced or metastatic breast cancer eligible for chemotherapy\n\nInitiated OV-based treatment as per SmPC for advanced breast cancer between January 2011 and December 2020 for the retrospective cohort or, initiating oral vinorelbine treatment at enrollment for the prospective cohort\n\nWilling and able to complete the QoL questionnaire, PPQ and WPAI questionnaire for the prospective cohort\n\nProvision of informed consent or non-opposition to the patient (or next of kin/legal representative, if applicable) for the use of data, according to local regulations\n\nExclusion Criteria:\n\nno exclusion criteria for patients in this study'}, 'identificationModule': {'nctId': 'NCT06500494', 'acronym': 'VINOREAL', 'briefTitle': 'To Describe How Well Vinorelbine Given Orally Works in Patients With a Breast Cancer After 2 Years of Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Medicament'}, 'officialTitle': 'Advanced Breast Cancer Patients Treated With Oral Vinorelbine: a Prospective and Retrospective, Observational Study - VINOREAL', 'orgStudyIdInfo': {'id': 'NIS16760'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective Cohort', 'description': 'Patients who initiated an oral vinorelbine treatment for advanced breast cancer over the 2011-2020 targeted enrollment period', 'interventionNames': ['Drug: Vinorelbine Tartrate Oral']}, {'label': 'Prospective Cohort', 'description': 'Patients initiating an oral vinorelbine treatment for advanced breast cancer at or after inclusion in the study and eligible for prospective collection of QoL data and PPQ and WPAI questionnaires', 'interventionNames': ['Drug: Vinorelbine Tartrate Oral']}], 'interventions': [{'name': 'Vinorelbine Tartrate Oral', 'type': 'DRUG', 'otherNames': ['Navelbine'], 'description': 'The recommended dosage for oral vinorelbine is 60 mg/m² of body surface area (BSA) administered once weekly for the first three weeks, followed by 80 mg/m² of BSA for the following weekly administration.', 'armGroupLabels': ['Prospective Cohort', 'Retrospective Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16000', 'city': 'Algiers', 'status': 'RECRUITING', 'country': 'Algeria', 'contacts': [{'name': 'Esma Kerboua, Pr', 'role': 'CONTACT', 'email': 'esmakerboua@yahoo.fr', 'phone': '00 213 23559767'}], 'facility': "Centre Hospitalo-Universitaire Mustapha, Hopital Mustapha, Place du 1er Mai 1945, Sidi M'Hamed", 'geoPoint': {'lat': 36.73225, 'lon': 3.08746}}, {'zip': '360060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yehui Shi, Pr', 'role': 'CONTACT', 'email': 'shiyehui@tjmuch.com', 'phone': '(0) 22-23340123'}], 'facility': 'Tianjing Medical University Cancer Institute & Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '20052', 'city': 'Monza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marina Elena Cazzaniga, Pr', 'role': 'CONTACT', 'email': 'marinaelena.cazzaniga@irccs-sangerardo.it', 'phone': '0039 02339037'}], 'facility': 'Azienda Ospedaliera San Gerardo U.O. Oncologia Medica', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}], 'centralContacts': [{'name': 'Cynthia Mourad, PharmD', 'role': 'CONTACT', 'email': 'cynthia.mourad@pierre-fabre.com', 'phone': '+33 6 31 02 00 69'}], 'overallOfficials': [{'name': 'Eric Garrigue, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pierre Fabre Medicament'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Medicament', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}