Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT04414202
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-02
First Post:
2020-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'drci-icm105@icm.unicancer.fr', 'phone': '0467613102', 'title': 'Mme Aurore Moussion, Director of Direction of Clinical Research and Innovation', 'phoneExt': '+33', 'organization': 'INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'collection from the baseline to 120 months after treatment by radiotherapy', 'description': 'adverse event collected with CTCAE. no serious adverse event appeared', 'eventGroups': [{'id': 'EG000', 'title': '1 GROUP', 'description': 'Patient with an Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery.\n\nThe treatment combines extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumor Follow up after this treatment will scheduled 10 years\n\ntumorectomy with axillary dissection (sentinel lymph node): All patients will have local excision of the primary tumor following appropriate clinical work-up. Surgery will be done according to usual local practice with a complete excision of the tumor. The aim of the local excision should be to achieve a minimum free margin of 2 mm whilst maintaining a good cosmetic outcome.\n\nper-operative partial irradiation: 20 Gy of per-operative partial irradiation at the tumor site during the surgery', 'otherNumAtRisk': 519, 'deathsNumAtRisk': 519, 'otherNumAffected': 519, 'seriousNumAtRisk': 519, 'deathsNumAffected': 39, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'atrophy', 'notes': 'atrophy grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cutaneous eruption', 'notes': 'cutaneous eruption grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fibrosis', 'notes': 'fibrosis grade 1, 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numEvents': 383, 'numAffected': 383}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperpigmentation', 'notes': 'hyperpigmentation grade 1 and 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numEvents': 97, 'numAffected': 97}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'erythema redness', 'notes': 'erythema redness grade 1 and 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numEvents': 38, 'numAffected': 38}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'telangiectasia', 'notes': 'telangiectasia grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ulceration', 'notes': 'ulceration grade 1 and 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patient With a Local Intra-mammary Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1 GROUP', 'description': 'Patient with an Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery.\n\nThe treatment combines extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumor Follow up after this treatment will scheduled 10 years\n\ntumorectomy with axillary dissection (sentinel lymph node): All patients will have local excision of the primary tumor following appropriate clinical work-up. Surgery will be done according to usual local practice with a complete excision of the tumor. The aim of the local excision should be to achieve a minimum free margin of 2 mm whilst maintaining a good cosmetic outcome.\n\nper-operative partial irradiation: 20 Gy of per-operative partial irradiation at the tumor site during the surgery'}], 'classes': [{'title': 'no relapse', 'categories': [{'measurements': [{'value': '498', 'groupId': 'OG000'}]}]}, {'title': 'local relapse', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'local and metastatic relapse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'not specified', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)', 'description': 'The local relapse rate, defined as the number of intramammary relapses in the treated breast (regardless of quadrant and including skin), appreciated at 5 years and 10 years. 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The aim of the local excision should be to achieve a minimum free margin of 2 mm whilst maintaining a good cosmetic outcome.\n\nper-operative partial irradiation: 20 Gy of per-operative partial irradiation at the tumor site during the surgery'}], 'classes': [{'title': 'at 3 weeks after the treatment', 'categories': [{'title': 'very good cosmetic result', 'measurements': [{'value': '208', 'groupId': 'OG000'}]}, {'title': 'good cosmetic result', 'measurements': [{'value': '124', 'groupId': 'OG000'}]}, {'title': 'bad cosmetic result', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'very bad cosmetic result', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'no data', 'measurements': [{'value': '175', 'groupId': 'OG000'}]}]}, {'title': 'at 6 months after the treatment', 'categories': [{'title': 'very good cosmetic result', 'measurements': [{'value': '198', 'groupId': 'OG000'}]}, {'title': 'good cosmetic result', 'measurements': [{'value': '147', 'groupId': 'OG000'}]}, {'title': 'bad cosmetic result', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'very bad cosmetic result', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'no data', 'measurements': [{'value': '159', 'groupId': 'OG000'}]}]}, {'title': 'at 12 months after the treatment', 'categories': [{'title': 'very good cosmetic result', 'measurements': [{'value': '256', 'groupId': 'OG000'}]}, {'title': 'good cosmetic result', 'measurements': [{'value': '99', 'groupId': 'OG000'}]}, {'title': 'bad cosmetic result', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'very bad cosmetic result', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'no data', 'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'post surgery : 3 weeks, 6 months and 12 months', 'description': 'Evaluation of the cosmetic result of questionnaire (0 "no satisfy with the cosmetic result"" from 10 "very satisfy with the cosmetic result")', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'the number of patient wich respond to the cosmetic questionnaire differs from the Overall Number of Participants Analyzed'}, {'type': 'SECONDARY', 'title': "Patients' Satisfaction Towards the Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1 GROUP', 'description': 'Patient with an Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery.\n\nThe treatment combines extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumor Follow up after this treatment will scheduled 10 years\n\ntumorectomy with axillary dissection (sentinel lymph node): All patients will have local excision of the primary tumor following appropriate clinical work-up. Surgery will be done according to usual local practice with a complete excision of the tumor. 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Surgery will be done according to usual local practice with a complete excision of the tumor. 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Surgery will be done according to usual local practice with a complete excision of the tumor. The aim of the local excision should be to achieve a minimum free margin of 2 mm whilst maintaining a good cosmetic outcome.\n\nper-operative partial irradiation: 20 Gy of per-operative partial irradiation at the tumor site during the surgery'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '69.54', 'groupId': 'BG000', 'lowerLimit': '59', 'upperLimit': '88'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '519', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2009-12-15', 'size': 377873, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-01T04:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 519}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2020-05-19', 'resultsFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2020-05-29', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-01', 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patient With a Local Intra-mammary Relapse', 'timeFrame': 'post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)', 'description': 'The local relapse rate, defined as the number of intramammary relapses in the treated breast (regardless of quadrant and including skin), appreciated at 5 years and 10 years. It will be assessed according to the recommendations applied to the Centre'}], 'secondaryOutcomes': [{'measure': 'Cosmetic Results', 'timeFrame': 'post surgery : 3 weeks, 6 months and 12 months', 'description': 'Evaluation of the cosmetic result of questionnaire (0 "no satisfy with the cosmetic result"" from 10 "very satisfy with the cosmetic result")'}, {'measure': "Patients' Satisfaction Towards the Treatment", 'timeFrame': 'post surgery : 3 weeks, 6 months and 12 months', 'description': 'Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)'}, {'measure': 'Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients', 'timeFrame': 'post surgery : 3 weeks, 6 months and 12 months', 'description': 'Assessment of the impact of this accelerated treatment on maintaining the autonomy of the subject by the use of geriatric scale (ADL (Activities of Daily Living), IADL (instrumental Activities of Daily Living)). (scale from 0 "no autonomy" to 10 "good autonomy")'}, {'measure': 'Overall Survival', 'timeFrame': 'from baseline to 10 years after treatment', 'description': 'rate of death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'good prognosis', 'surgery', 'intra-operative partial irradiation'], 'conditions': ['Invasive Breast Cancer', 'Breast-conserving Surgery']}, 'referencesModule': {'references': [{'pmid': '11768604', 'type': 'BACKGROUND', 'citation': "Grosclaude P, Colonna M, Hedelin G, Tretarre B, Arveux P, Lesec'h JM, Raverdy N, Sauvage-Machelard M. Survival of women with breast cancer in france: variation with age, stage and treatment. Breast Cancer Res Treat. 2001 Nov;70(2):137-43. doi: 10.1023/a:1012974728007."}, {'pmid': '10904087', 'type': 'BACKGROUND', 'citation': 'van Dongen JA, Voogd AC, Fentiman IS, Legrand C, Sylvester RJ, Tong D, van der Schueren E, Helle PA, van Zijl K, Bartelink H. Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. J Natl Cancer Inst. 2000 Jul 19;92(14):1143-50. doi: 10.1093/jnci/92.14.1143.'}, {'pmid': '12393819', 'type': 'BACKGROUND', 'citation': 'Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989.'}, {'pmid': '16360786', 'type': 'BACKGROUND', 'citation': "Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7."}, {'pmid': '17577015', 'type': 'BACKGROUND', 'citation': 'Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. doi: 10.1200/JCO.2007.11.4991. Epub 2007 Jun 18.'}, {'pmid': '9263806', 'type': 'BACKGROUND', 'citation': 'Dubois JB, Hay M, Gely S, Saint-Aubert B, Rouanet P, Pujol H. IORT in breast carcinomas. Front Radiat Ther Oncol. 1997;31:131-7. doi: 10.1159/000061160. No abstract available.'}, {'pmid': '16442241', 'type': 'BACKGROUND', 'citation': 'Lemanski C, Azria D, Thezenas S, Gutowski M, Saint-Aubert B, Rouanet P, Fenoglietto P, Ailleres N, Dubois JB. Intraoperative radiotherapy given as a boost for early breast cancer: long-term clinical and cosmetic results. Int J Radiat Oncol Biol Phys. 2006 Apr 1;64(5):1410-5. doi: 10.1016/j.ijrobp.2005.10.025. Epub 2006 Jan 25.'}, {'pmid': '19467579', 'type': 'BACKGROUND', 'citation': 'Lemanski C, Azria D, Gourgon-Bourgade S, Gutowski M, Rouanet P, Saint-Aubert B, Ailleres N, Fenoglietto P, Dubois JB. Intraoperative radiotherapy in early-stage breast cancer: results of the montpellier phase II trial. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):698-703. doi: 10.1016/j.ijrobp.2009.02.039. Epub 2009 May 23.'}, {'pmid': '19632605', 'type': 'BACKGROUND', 'citation': 'Smith BD, Arthur DW, Buchholz TA, Haffty BG, Hahn CA, Hardenbergh PH, Julian TB, Marks LB, Todor DA, Vicini FA, Whelan TJ, White J, Wo JY, Harris JR. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). J Am Coll Surg. 2009 Aug;209(2):269-77. doi: 10.1016/j.jamcollsurg.2009.02.066. Epub 2009 Apr 24. No abstract available.'}, {'pmid': '12393820', 'type': 'BACKGROUND', 'citation': 'Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.'}, {'pmid': '11571720', 'type': 'BACKGROUND', 'citation': 'Vlastos G, Mirza NQ, Meric F, Hunt KK, Kuerer HM, Ames FC, Ross MI, Buchholz TA, Hortobagyi GN, Singletary SE. Breast conservation therapy as a treatment option for the elderly. The M. D. Anderson experience. Cancer. 2001 Sep 1;92(5):1092-100. doi: 10.1002/1097-0142(20010901)92:53.0.co;2-p.'}, {'pmid': '14734701', 'type': 'BACKGROUND', 'citation': 'Vinh-Hung V, Verschraegen C. Breast-conserving surgery with or without radiotherapy: pooled-analysis for risks of ipsilateral breast tumor recurrence and mortality. J Natl Cancer Inst. 2004 Jan 21;96(2):115-21. doi: 10.1093/jnci/djh013.'}], 'seeAlsoLinks': [{'url': 'https://www.e-cancer.fr/', 'label': 'Institut de Veille Sanitaire- Institut National du Cancer'}]}, 'descriptionModule': {'briefSummary': 'Due to screening, T1N0 early-stage breast cancer now accounts for more than 50% of the tumors diagnosed in France. The prognosis of these tumors is good, even excellent in women ≥ 65 years of age, with specific survival of 98% at 5 years.\n\nThe treatment of these tumors combines breast-conserving surgery and external whole breast irradiation for 6.5 weeks.\n\nA true de-escalation of treatment is taking place with these tumors, both surgically and medically. Surgery therefore now prefers breast-conserving methods in combination with exeresis of the sentinel lymph node only. In the same way, in many international studies, radiotherapy has been evaluating the possibility of reducing both:\n\n* the irradiation volume at the excision site (partial irradiation)\n* the duration of this irradiation (accelerated radiotherapy)\n\nBetween 2004 and 2007, the CRLC \\[Regional Anti-Cancer Center\\] evaluated the feasibility and the oncological results of intra-operative partial irradiation via a phase II study in women 65 years of age and older with T1N0M0 hormone-sensitive tumors with a good prognosis.\n\nFrom 2010 to 2013, the ICM carried out an observational study of these tumors with an excellent prognosis.\n\nIn July 2009, the American Society for Radiation Oncology (ASTRO) published a consensus statement with specific recommendations and indications for accelerated partial breast irradiation (APBI).\n\nThis APBI technique has been developing in France over the past 5 years within the framework of clinical studies and in compliance with the 2012 recommendations of the French National Cancer Institute. This APBI can be given by 3D external radiotherapy or, as in this study, by intra-operative radiotherapy (IORT) in order to obtain optimal precision and spare as much of the surrounding healthy tissue as possible.\n\nThe Investigator therefore propose a cohort study to prospectively analyze the results of this technique applied to the indications strictly defined by the ASTRO.', 'detailedDescription': 'after registration, particpants have as treatment "combination extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumor site.\n\nfollow up after this treatment during 5 years'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 60 years of age or older,\n* Histologically proven invasive ductal breast cancer or of a histologically favorable sub-type (mucinous, tubular or colloid),\n\n -. Unifocal tumor,\n* T1 (diameter ≤ 20 mm),\n* N0 (pN0 or pNi+),\n* M0,\n* Gland exeresis margins ≥ 2 mm,\n* Estrogen receptor positive,\n* Information and non-opposition of the patient.\n\nExclusion Criteria:\n\n-. Inflammatory breast cancer,\n\n* Associated peri-tumoral lymphatic emboli\n* Associated extensive intra-ductal component\n* Invasive lobular carcinoma\n* Pure ductal carcinoma in situ,\n* Sarcoma or lymphoma-type non-epithelial tumor\n* Synchronous bilateral breast cancer,\n* Any prior neo-adjuvant treatment: radiotherapy, chemotherapy, hormone therapy'}, 'identificationModule': {'nctId': 'NCT04414202', 'acronym': 'INTRA-OBS', 'briefTitle': 'Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis', 'orgStudyIdInfo': {'id': '2009/OBS-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1 GROUP', 'description': 'Patient with an Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery.\n\nThe treatment combines extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumor Follow up after this treatment will scheduled 10 years', 'interventionNames': ['Procedure: tumorectomy with axillary dissection (sentinel lymph node)', 'Radiation: per-operative partial irradiation']}], 'interventions': [{'name': 'tumorectomy with axillary dissection (sentinel lymph node)', 'type': 'PROCEDURE', 'description': 'All patients will have local excision of the primary tumor following appropriate clinical work-up. Surgery will be done according to usual local practice with a complete excision of the tumor. The aim of the local excision should be to achieve a minimum free margin of 2 mm whilst maintaining a good cosmetic outcome.', 'armGroupLabels': ['1 GROUP']}, {'name': 'per-operative partial irradiation', 'type': 'RADIATION', 'description': '20 Gy of per-operative partial irradiation at the tumor site during the surgery', 'armGroupLabels': ['1 GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34398', 'city': 'Montpellier', 'state': 'Herault', 'country': 'France', 'facility': "Icm Val D'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'LEMANSKI Claire, DR', 'role': 'STUDY_CHAIR', 'affiliation': "ICM Val d'Aurelle DRCI"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}