Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-01-07 @ 7:32 AM
Study NCT ID:
NCT03664895
Status:
UNKNOWN
Last Update Posted:
2023-12-04
First Post:
2018-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Density Lowering Effect of "OFS Add on to TMX"(DELFINO Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'D017273', 'term': 'Goserelin'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2018-09-07', 'studyFirstSubmitQcDate': '2018-09-07', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'overall survival', 'timeFrame': '5 years'}], 'primaryOutcomes': [{'measure': 'MMG density Reduction', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['premenopausal women, MMG density, Ovary function suppression'], 'conditions': ['Breast Cancer Invasive']}, 'descriptionModule': {'briefSummary': 'DELFINO tial is designed to investigate the role of "OFS add on to TMX ", based on MMG density as a surrogate marker in premenopausal women\n\n* Premise - MMG density as a surrogate marker of hormone therapy\n* Assumption - "Add on OFS to TMX" would have further decrease of density\n\n * 3-arm(Observation arm + Randomised 2-arm), phase III, RCT with 1:1 allocation', 'detailedDescription': 'Enroll : Sep03,2018\\~(Planned N= 224)\n\n1. Inclusion criteria\n\n * Premenopausal\n * ER+\n * Planned tamoxifen(TMX)\n * No planned ovary function suppression(OFS)\n * Regardless of ChemoTx\n * Mammography(MMG) density check via Volpara\\*(=Baseline MMG density, BaMD) (\\*Volpara= software to check MMG density)\n2. Check MMG Density via Volpara After 1yr TMX (At1yrMD) Check menopausal status after 1yr TMX(Menstruation episode or FSH \\<30)\n3. MMG Density Reduction(MDR =BaMD-AtMD ) at 1yr\n4. MDR ≥5% -\\> Keep go on TMX MDR \\<5% -\\> 1:1 randomization -\\> Keep go on TMX vs OFS add on to TMX\n5. Analysis : 5yr MDR (1\'endpoint), 5yr DFS(2\'endpoint), 5yr OS\n6. Calculation of patients\' number In previous study(\\<Kim et al. Breast Can Res 2012\\>) MDR (Mammography Density Reduction) was found in about 50% of all patients who received endocrine therapy.\n\nExpected\n\n* MDR in "TMX only" cohort -\\> 6 ± 7%\n* MDR in "OFS add on to TMX" -\\> 10 ± 7%\n\n * after 1yr, Significance level 5%, average MDR 4% difference, 80% power, 10% dropout rate =\\> 1:1 randomization Number = 112(56:56) Total number = 224'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal women, ER+ breast cancer, stage I\\~III, underwent standard treatment including surgery, Planned TMX\n* available MMG density check via Volpara\n\nExclusion Criteria:\n\n* Bilateral breast cancer\n* Prior endocrine therapy\n* Postmenopausal status\n* unavailable MMG density check via volpara before and after TMX'}, 'identificationModule': {'nctId': 'NCT03664895', 'briefTitle': 'Density Lowering Effect of "OFS Add on to TMX"(DELFINO Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Density Lowering Effect of Ovarian Function Suppression in Premenopausal Breast Cancer Patients Who Had no Density Change With One Year of Tamoxifen Treatment', 'orgStudyIdInfo': {'id': 'DELFINO trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'observation arm(TMX, MDR≥5%)', 'description': 'keep go on TMX'}, {'type': 'NO_INTERVENTION', 'label': 'control arm(TMX, MDR<5%)', 'description': 'keep go on TMX'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OFS add arm(TMX + OFS, MDR<5%)', 'description': 'OFS add on to TMX', 'interventionNames': ['Drug: Leuplin or zoladex']}], 'interventions': [{'name': 'Leuplin or zoladex', 'type': 'DRUG', 'description': 'OFS(Leuplin or zoladex) add on to TMX', 'armGroupLabels': ['OFS add arm(TMX + OFS, MDR<5%)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Wonshik Han, MD PhD', 'role': 'CONTACT', 'email': 'hanw@snu.ac.kr', 'phone': '82-2-2072-1958'}, {'name': 'Eun-Shin Lee, MD', 'role': 'CONTACT', 'email': 'silvershoe99@gmail.com'}, {'name': 'Eun-Shin Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Eun-Shin Lee', 'role': 'CONTACT', 'email': 'silvershoe99@gmail.com', 'phone': '82-2-2072-0173'}], 'overallOfficials': [{'name': 'Wonshik Han', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University College of Medicine/Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}