Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-02-27 @ 7:05 PM
Study NCT ID:
NCT06637202
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swebcg 91:A RT. Breast Conserving Surgery With or Without Radiotherapy for Breast Cancer Patients
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1187}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1991-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2024-10-10', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '1996-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Loco-regional recurrence', 'timeFrame': '35 years', 'description': 'Recurrence in the breast or regional lymph nodes'}], 'secondaryOutcomes': [{'measure': 'survival', 'timeFrame': '35 years', 'description': 'Does radiotherapy have an impact on survival?'}, {'measure': 'Secondary malignancies', 'timeFrame': '35 years', 'description': 'Does radiotherapy have an impact on secondandary malignancies?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'radiotherapy'], 'conditions': ['Breast Cancer Early Stage Breast Cancer (Stage 1-3)']}, 'referencesModule': {'references': [{'pmid': '36599119', 'type': 'RESULT', 'citation': 'Sjostrom M, Fyles A, Liu FF, McCready D, Shi W, Rey-McIntyre K, Chang SL, Feng FY, Speers CW, Pierce LJ, Holmberg E, Ferno M, Malmstrom P, Karlsson P. Development and Validation of a Genomic Profile for the Omission of Local Adjuvant Radiation in Breast Cancer. J Clin Oncol. 2023 Mar 10;41(8):1533-1540. doi: 10.1200/JCO.22.00655. Epub 2023 Jan 4.'}, {'pmid': '33661437', 'type': 'RESULT', 'citation': 'Strell C, Stenmark Tullberg A, Jetne Edelmann R, Akslen LA, Malmstrom P, Ferno M, Holmberg E, Ostman A, Karlsson P. Prognostic and predictive impact of stroma cells defined by PDGFRb expression in early breast cancer: results from the randomized SweBCG91RT trial. Breast Cancer Res Treat. 2021 May;187(1):45-55. doi: 10.1007/s10549-021-06136-4. Epub 2021 Mar 4.'}, {'pmid': '31618132', 'type': 'RESULT', 'citation': 'Sjostrom M, Chang SL, Fishbane N, Davicioni E, Zhao SG, Hartman L, Holmberg E, Feng FY, Speers CW, Pierce LJ, Malmstrom P, Ferno M, Karlsson P. Clinicogenomic Radiotherapy Classifier Predicting the Need for Intensified Locoregional Treatment After Breast-Conserving Surgery for Early-Stage Breast Cancer. J Clin Oncol. 2019 Dec 10;37(35):3340-3349. doi: 10.1200/JCO.19.00761. Epub 2019 Oct 16.'}, {'pmid': '31558478', 'type': 'RESULT', 'citation': 'Sjostrom M, Chang SL, Fishbane N, Davicioni E, Hartman L, Holmberg E, Feng FY, Speers CW, Pierce LJ, Malmstrom P, Ferno M, Karlsson P. Comprehensive Transcriptomic Profiling Identifies Breast Cancer Patients Who May Be Spared Adjuvant Systemic Therapy. Clin Cancer Res. 2020 Jan 1;26(1):171-182. doi: 10.1158/1078-0432.CCR-19-1038. Epub 2019 Sep 26.'}, {'pmid': '37208129', 'type': 'RESULT', 'citation': 'Stenmark Tullberg A, Sjostrom M, Tran L, Nimeus E, Killander F, Kovacs A, Lundstedt D, Holmberg E, Karlsson P. Combining histological grade, TILs, and the PD-1/PD-L1 pathway to identify immunogenic tumors and de-escalate radiotherapy in early breast cancer: a secondary analysis of a randomized clinical trial. J Immunother Cancer. 2023 May;11(5):e006618. doi: 10.1136/jitc-2022-006618.'}, {'pmid': '37071498', 'type': 'RESULT', 'citation': 'Stenmark Tullberg A, Sjostrom M, Nimeus E, Killander F, Chang SL, Feng FY, Speers CW, Pierce LJ, Kovacs A, Lundstedt D, Holmberg E, Karlsson P. Integrating Tumor-Intrinsic and Immunologic Factors to Identify Immunogenic Breast Cancers from a Low-Risk Cohort: Results from the Randomized SweBCG91RT Trial. Clin Cancer Res. 2023 May 1;29(9):1783-1793. doi: 10.1158/1078-0432.CCR-22-2746.'}, {'pmid': '36975842', 'type': 'RESULT', 'citation': 'Egelberg M, De Marchi T, Pekar G, Tran L, Bendahl PO, Tullberg AS, Holmberg E, Karlsson P, Farnebo M, Killander F, Nimeus E. Low levels of WRAP53 predict decreased efficacy of radiotherapy and are prognostic for local recurrence and death from breast cancer: a long-term follow-up of the SweBCG91RT randomized trial. Mol Oncol. 2023 Oct;17(10):2029-2040. doi: 10.1002/1878-0261.13426. Epub 2023 Apr 19.'}, {'pmid': '35140341', 'type': 'RESULT', 'citation': 'Tutzauer J, Sjostrom M, Holmberg E, Karlsson P, Killander F, Leeb-Lundberg LMF, Malmstrom P, Nimeus E, Ferno M, Jogi A. Breast cancer hypoxia in relation to prognosis and benefit from radiotherapy after breast-conserving surgery in a large, randomised trial with long-term follow-up. Br J Cancer. 2022 May;126(8):1145-1156. doi: 10.1038/s41416-021-01630-4. Epub 2022 Feb 9.'}, {'pmid': '32302682', 'type': 'RESULT', 'citation': 'Killander F, Wieslander E, Karlsson P, Holmberg E, Lundstedt D, Holmberg L, Werner L, Koul S, Haghanegi M, Kjellen E, Nilsson P, Malmstrom P. No Increased Cardiac Mortality or Morbidity of Radiation Therapy in Breast Cancer Patients After Breast-Conserving Surgery: 20-Year Follow-up of the Randomized SweBCGRT Trial. Int J Radiat Oncol Biol Phys. 2020 Jul 15;107(4):701-709. doi: 10.1016/j.ijrobp.2020.04.003. Epub 2020 Apr 14.'}, {'pmid': '33148672', 'type': 'RESULT', 'citation': 'Stenmark Tullberg A, Puttonen HAJ, Sjostrom M, Holmberg E, Chang SL, Feng FY, Speers C, Pierce LJ, Lundstedt D, Killander F, Nimeus E, Kovacs A, Karlsson P. Immune Infiltrate in the Primary Tumor Predicts Effect of Adjuvant Radiotherapy in Breast Cancer; Results from the Randomized SweBCG91RT Trial. Clin Cancer Res. 2021 Feb 1;27(3):749-758. doi: 10.1158/1078-0432.CCR-20-3299. Epub 2020 Nov 4.'}, {'pmid': '32946618', 'type': 'RESULT', 'citation': 'Sjostrom M, Veenstra C, Holmberg E, Karlsson P, Killander F, Malmstrom P, Nimeus E, Ferno M, Stal O. Expression of HGF, pMet, and pAkt is related to benefit of radiotherapy after breast-conserving surgery: a long-term follow-up of the SweBCG91-RT randomised trial. Mol Oncol. 2020 Nov;14(11):2713-2726. doi: 10.1002/1878-0261.12803. Epub 2020 Sep 28.'}, {'pmid': '27614164', 'type': 'RESULT', 'citation': 'Killander F, Karlsson P, Anderson H, Mattsson J, Holmberg E, Lundstedt D, Holmberg L, Malmstrom P. No breast cancer subgroup can be spared postoperative radiotherapy after breast-conserving surgery. Fifteen-year results from the Swedish Breast Cancer Group randomised trial, SweBCG 91 RT. Eur J Cancer. 2016 Nov;67:57-65. doi: 10.1016/j.ejca.2016.08.001. Epub 2016 Sep 7.'}, {'pmid': '20970212', 'type': 'RESULT', 'citation': 'Lundstedt D, Gustafsson M, Malmstrom P, Johansson KA, Alsadius D, Sundberg A, Wilderang U, Holmberg E, Anderson H, Steineck G, Karlsson P. Symptoms 10-17 years after breast cancer radiotherapy data from the randomised SWEBCG91-RT trial. Radiother Oncol. 2010 Nov;97(2):281-7. doi: 10.1016/j.radonc.2010.09.018. Epub 2010 Oct 20.'}, {'pmid': '40022029', 'type': 'DERIVED', 'citation': 'Egelberg M, De Marchi T, Schultz N, Tran L, Karlsson P, Holmberg E, Pekar G, Killander F, Nimeus E. The potential radiosensitization target PFKFB3 is related to response to radiotherapy in SweBCG91RT: a randomized clinical trial with long-term follow-up. BMC Cancer. 2025 Feb 28;25(1):374. doi: 10.1186/s12885-025-13703-1.'}]}, 'descriptionModule': {'briefSummary': 'The main goal of the trial was to analyse the value of radiotherapy after breast conserving surgery for patients with breast cancer, and to find groups of patients where the treatment could be omitted.', 'detailedDescription': 'The trial recruited patients between 1991-1996, and the primary outcome in terms of recurrences has been updated through the years since then. Tumour material has been collected in order to study prognostic and predictive factors for breast cancer patients that are treated today. Late side effects of the treatment are studied.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* not over the age of 75 years\n* operated because of stage 1-2 invasive adenocarcinoma of the breast\n* radical excision of the tumour\n\nExclusion Criteria:\n\n* earlier cancer except cancer in situ of the cervix or skin\n* distant metastases'}, 'identificationModule': {'nctId': 'NCT06637202', 'briefTitle': 'Swebcg 91:A RT. Breast Conserving Surgery With or Without Radiotherapy for Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'SB (Swedish Breast Cancer Group) 91:A Breast Conserving Surgery With or Without Postoperative Radiotherapy for Breast Cancer Stage 1-2 (<30 mm) pN0, M0', 'orgStudyIdInfo': {'id': 'LU 80/90'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'postoperative radiotherapy', 'description': 'Patients were treated with radiotherapy to 50 Gy in 25 fractions', 'interventionNames': ['Radiation: postoperative radiotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Patients received no further treatment after surgery'}], 'interventions': [{'name': 'postoperative radiotherapy', 'type': 'RADIATION', 'description': '50 Gy in 25 fractions', 'armGroupLabels': ['postoperative radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lund', 'country': 'Sweden', 'facility': 'Region Skane', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Karlsson Per, MD, prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Göteborg University, Västra Götaland Region'}, {'name': 'Erik Holmberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Göteborg University'}, {'name': 'Emma Nimeus Malmström, MD, ass prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University, Region Skane'}, {'name': 'Fredrika Killander, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Skane, Lund University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This trial started in 1990'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}