Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT05333328
Status:
RECRUITING
Last Update Posted:
2025-05-22
First Post:
2022-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'De-escalating treatment as ovarian-function suppression with endocrine treatments alone in ER+HER2- premenopausal women with N1'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 418}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2033-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-18', 'studyFirstSubmitDate': '2022-04-11', 'studyFirstSubmitQcDate': '2022-04-11', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distant recurrence-free survival', 'timeFrame': '5-years distant recurrence-free survival', 'description': 'The interval between the date of primary surgery and the date of last censored, or distant recurrence or death of any cause'}], 'secondaryOutcomes': [{'measure': 'Recurrence-free survival (RFS)', 'timeFrame': '5-years RFS', 'description': 'The interval between the date of primary surgery and the date of last censored, or any type of recurrence or death of any cause'}, {'measure': 'Invasive disease-free survival (iDFS)', 'timeFrame': '5-years iDFS', 'description': 'The interval between the date of primary surgery and the date of last censored, or any type of invasive disease except thyroid cancer or death of any cause'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Estrogen Receptor Positive Tumor', 'HER2-negative Breast Cancer', 'Premenopausal Breast Cancer', 'Node-positive Breast Cancer', 'Multigene assay', 'Ovarian-function suppression'], 'conditions': ['Breast Cancer', 'Estrogen Receptor Positive Tumor', 'HER2-negative Breast Cancer', 'Premenopausal Breast Cancer', 'Node-positive Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®).\n\nIn these, ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.', 'detailedDescription': '* Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®).\n* In these, ovarian function suppression (OFS) with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.\n* Either goserelin acetate or leuprorelin Acetate is allowed.\n* These patients are able to choose bilateral salpingo-oophorectomy instead of OFS.\n* Chemotherapy is omitted in these patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ER+HER2- breast cancer\n* Premenopausal and age \\<=50\n* T1 or T2\n* N1 including micrometastasis\n* Genomic Low Risk by OncoFREE test® (1-20)\n\nExclusion Criteria:\n\n* Postmenopausal women\n* ER-negative breast cancer'}, 'identificationModule': {'nctId': 'NCT05333328', 'acronym': 'INTERSTELLAR', 'briefTitle': 'OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)', 'orgStudyIdInfo': {'id': '2021-1151-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OFS with endocrine', 'description': 'Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, the patients with a genomic low risk using the multigene-assay (OncoFREE®) will be included in this arm.', 'interventionNames': ['Drug: Ovarian function suppression with endocrine treatments']}], 'interventions': [{'name': 'Ovarian function suppression with endocrine treatments', 'type': 'DRUG', 'description': '* Ovarian function suppression (OFS) with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.\n* Either goserelin acetate or leuprorelin Acetate is allowed.\n* These patients are able to choose bilateral salpingo-oophorectomy instead of OFS.\n* Chemotherapy is omitted in these patients.', 'armGroupLabels': ['OFS with endocrine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06229', 'city': 'Seoul', 'state': 'Korea', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung Gwe Ahn, MD, PhD', 'role': 'CONTACT', 'email': 'asg2004@yuhs.ac', 'phone': '0220193370'}, {'role': 'CONTACT', 'email': 'asg2004@yuhs.ac'}, {'name': 'Sung Gwe Ahn, MD.,PH.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyeoung Gon Moon', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sung Gwe Ahn, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'asg2004@yuhs.ac', 'phone': '0220193370'}], 'overallOfficials': [{'name': 'Sung Gwe Ahn, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gangnam Severance Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'Sung Gwe Ahn', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}