Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT02941835
Status:
TERMINATED
Last Update Posted:
2019-10-22
First Post:
2016-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Breast Irradiation
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': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'slow inclusion rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-18', 'studyFirstSubmitDate': '2016-10-20', 'studyFirstSubmitQcDate': '2016-10-20', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'gene expression profiles', 'timeFrame': '6 weeks', 'description': 'at start a biopsy will be taken and compared to the surgical specimen at 6 weeks post treatment'}], 'primaryOutcomes': [{'measure': 'Postoperative surgical complications', 'timeFrame': 'within six weeks after surgery', 'description': 'postoperative complication will be scored by a specific list'}], 'secondaryOutcomes': [{'measure': 'Radiological response', 'timeFrame': '6 weeks post-radiation', 'description': 'assessed by MRI'}, {'measure': 'Pathological response', 'timeFrame': 'at surgery', 'description': 'surgery specimen'}, {'measure': 'cosmetic outcome', 'timeFrame': '1,3 and 5 years post-treatment', 'description': 'cosmesis will be scored by physician by questionnaire and cosmesis will be cored by patient by questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pre-operative radiotherapy'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '25500422', 'type': 'BACKGROUND', 'citation': 'Bartelink H, Maingon P, Poortmans P, Weltens C, Fourquet A, Jager J, Schinagl D, Oei B, Rodenhuis C, Horiot JC, Struikmans H, Van Limbergen E, Kirova Y, Elkhuizen P, Bongartz R, Miralbell R, Morgan D, Dubois JB, Remouchamps V, Mirimanoff RO, Collette S, Collette L; European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups. Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial. Lancet Oncol. 2015 Jan;16(1):47-56. doi: 10.1016/S1470-2045(14)71156-8. Epub 2014 Dec 9.'}, {'pmid': '24743607', 'type': 'BACKGROUND', 'citation': 'Donker M, Straver ME, Wesseling J, Loo CE, Schot M, Drukker CA, van Tinteren H, Sonke GS, Rutgers EJ, Vrancken Peeters MJ. Marking axillary lymph nodes with radioactive iodine seeds for axillary staging after neoadjuvant systemic treatment in breast cancer patients: the MARI procedure. Ann Surg. 2015 Feb;261(2):378-82. doi: 10.1097/SLA.0000000000000558.'}, {'pmid': '26017612', 'type': 'BACKGROUND', 'citation': 'Egro FM, Pinell-White X, Hart AM, Losken A. The use of reduction mammaplasty with breast conservation therapy: an analysis of timing and outcomes. Plast Reconstr Surg. 2015 Jun;135(6):963e-971e. doi: 10.1097/PRS.0000000000001274.'}, {'pmid': '19720914', 'type': 'BACKGROUND', 'citation': 'Jones HA, Antonini N, Hart AA, Peterse JL, Horiot JC, Collin F, Poortmans PM, Oei SB, Collette L, Struikmans H, Van den Bogaert WF, Fourquet A, Jager JJ, Schinagl DA, Warlam-Rodenhuis CC, Bartelink H. Impact of pathological characteristics on local relapse after breast-conserving therapy: a subgroup analysis of the EORTC boost versus no boost trial. J Clin Oncol. 2009 Oct 20;27(30):4939-47. doi: 10.1200/JCO.2008.21.5764. Epub 2009 Aug 31.'}, {'pmid': '12490681', 'type': 'BACKGROUND', 'citation': "van de Vijver MJ, He YD, van't Veer LJ, Dai H, Hart AA, Voskuil DW, Schreiber GJ, Peterse JL, Roberts C, Marton MJ, Parrish M, Atsma D, Witteveen A, Glas A, Delahaye L, van der Velde T, Bartelink H, Rodenhuis S, Rutgers ET, Friend SH, Bernards R. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med. 2002 Dec 19;347(25):1999-2009. doi: 10.1056/NEJMoa021967."}]}, 'descriptionModule': {'briefSummary': 'The PROBI is a phase I/II trial assessing the feasibility of preoperative whole breast irradiation in female patients with low to intermediate risk breast cancer, who undergo breast conserving therapy, including a boost dose of irradiation.\n\nAn additional goal of this study is to assess tumor response to radiotherapy, by imaging modalities (PET-CT and MRI) and pathology'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven invasive breast carcinoma\n* cT1-2N0 breast cancer\n* cM0\n* female patients ≤ 50 years\n* planned breast conserving surgery\n* ability to undergo irradiation and surgery\n* signed written informed consent\n\nExclusion Criteria:\n\n* prior surgery or radiotherapy for the protocol tumor (neoadjuvant chemotherapy or endocrine therapy is allowed)\n* planned oncoplastic reduction mammoplasty\n* cTis\n* extensive calcifications on mammagram (Birads 3,4 or 5)\n* cT3-4 and/or cN1-3 invasive carcinoma\n* distant metastasis'}, 'identificationModule': {'nctId': 'NCT02941835', 'acronym': 'PROBI', 'briefTitle': 'Preoperative Breast Irradiation', 'organization': {'class': 'OTHER', 'fullName': 'The Netherlands Cancer Institute'}, 'officialTitle': 'Preoperative Breast Irradiation, the PROBI Trial. A Phase I/II Feasibility Trial', 'orgStudyIdInfo': {'id': 'N16PRB'}, 'secondaryIdInfos': [{'id': 'NL59561.031.16', 'type': 'REGISTRY', 'domain': 'CCMO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'radiation', 'description': 'intervention: pre-operative breast irradiation of 21 fx of 2.2Gy and boost 2.66Gy', 'interventionNames': ['Radiation: pre-operative irradiation']}], 'interventions': [{'name': 'pre-operative irradiation', 'type': 'RADIATION', 'otherNames': ['radiotherapy'], 'description': 'pre-operative whole breast irradiation of 21 fx of 2.2Gy and boost of 2.66Gy', 'armGroupLabels': ['radiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Netherlands Cancer Institute', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Astrid Scholten, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Antoni van Leeuwenhoek'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Netherlands Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}