Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-02-26 @ 12:41 AM
Study NCT ID:
NCT02834494
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2016-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Response to Neo-adjuvant Chemotherapy for Patients With a Locally Advanced Breast Cancer With 3D Elastography (Shear Wave), NEOELASTO
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': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2016-07-08', 'studyFirstSubmitQcDate': '2016-07-12', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy', 'timeFrame': 'up to 32 months', 'description': 'Measure of the tumor prior to neoadjuvant chemotherapy (T0), at T1 and T2(1stand 2nd courses of anthracycline), at mid-treatment between anthracycline and taxane chemotherapy (Tmi), at the end of chemotherapy before surgery (Tfin).'}], 'secondaryOutcomes': [{'measure': 'Elastic properties before treatment (especially ratio between tumor and glandular breast or fat tissues close to the tumors)', 'timeFrame': 'up to 32 months', 'description': 'Use technic Supersonic Shear Imaging.'}, {'measure': 'peritumoral environmental elasticity properties', 'timeFrame': 'up to 32 months', 'description': 'Use technic Supersonic Shear Imaging (Explorer, Supersonic Imagine).'}, {'measure': 'Reliable early biomarker of histological response.', 'timeFrame': 'up to 32 months', 'description': "Estimate under chemotherapy if early changes in tumor's elasticity can provide a reliable early biomarker of histological response."}, {'measure': 'tumor volume changes under treatment by 3D ultrasound', 'timeFrame': 'up to 32 months', 'description': 'Estimate tumor volume changes under treatment by 3D ultrasound and Compare with measurements obtained by other conventional imaging methods currently used for monitoring patients under neoadjuvant chemotherapy'}, {'measure': 'Compare changes in tumor elasticity under chemotherapy to variables obtained by other imaging modalities (Breast MRI) performed in clinical routine', 'timeFrame': 'up to 32 months'}, {'measure': 'Compare changes in tumor elasticity under neoadjuvant chemotherapy to changes in diffusion apparent coefficient by using technic Supersonic Shear Imaging (Explorer, Supersonic Imagine).', 'timeFrame': 'up to 32 months'}, {'measure': 'Compare changes in tumor volume to histological response (Gold Standard : surgery after neoadjuvant chemotherapy according to " Residual Cancer Burden " score', 'timeFrame': 'up to 32 months'}, {'measure': 'Compare predictive value (semi-quantitative et quantitative measurements) of tumor elasticity', 'timeFrame': 'up to 32 months'}, {'measure': 'Assess vascular shape and its evolution under treatment by Ultrasensitive Doppler technic "Ultra-Fast Doppler"', 'timeFrame': 'up to 32 months'}, {'measure': 'Compare tumor elasticity to conventional histological parameters', 'timeFrame': '6 weeks', 'description': 'For the additional biopsy (optional) under neoadjuvant chemotherapy at T2, correlation elastography to pathological parameters of peritumoral environment by analyzing conventional histological parameters.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['locally advanced breast cancer', 'neoadjuvant chemotherapy'], 'conditions': ['Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy in patients with locally advanced breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infiltrating Breast Cancer untreated and/or locally advanced (stages I (T1c), IIa IIb, IIIa, IIIb, IIIc of UICC classification), whatever histological type.\n* Neo-adjuvant chemotherapy decided.(Anthracyclines, taxanes and, for tumors overexpressing human epidermal growth factor receptor 2 (HER2) protein, targeted recombinant humanized monoclonal antibodies)\n* Index tumor whose dimensions are between 10 to 50 mm. Multifocality, and/or multicentricity and/or bilaterality accepted (maximum 2 tumors by breast et tumors well differentiated from each other).\n* Patients aged at least 18 years old at diagnosis\n* Full results conventional breast exams available and no reason to achieve MRI breast exam\n* Patient explanation given and consent information signed\n\nExclusion Criteria:\n\n* Pregnant or during lactation\n* Personal history of ipsilateral breast cancer (ipsilateral recurrence or second cancer in the same breast).\n* Patient carrier of cosmetic breast implants\n* Person deprived of liberty or under guardianship\n* Contraindication for receiving neo-adjuvant chemotherapy for any medical reason\n* Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.'}, 'identificationModule': {'nctId': 'NCT02834494', 'acronym': 'NEO-ELASTO', 'briefTitle': 'Assessment of Response to Neo-adjuvant Chemotherapy for Patients With a Locally Advanced Breast Cancer With 3D Elastography (Shear Wave), NEOELASTO', 'organization': {'class': 'OTHER', 'fullName': 'Institut Curie'}, 'officialTitle': '3D Elastography (Shear Wave) : Assessment of Response to Neo-adjuvant Chemotherapy (NACT) : in Vivo Quantification, for Patients With a Locally Advanced Breast Cancer.', 'orgStudyIdInfo': {'id': 'IC 2015-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '3D Shear Wave Elastography (SWE)', 'interventionNames': ['Procedure: 3D Shear Wave Elastography (SWE)', 'Biological: Biopsy']}], 'interventions': [{'name': '3D Shear Wave Elastography (SWE)', 'type': 'PROCEDURE', 'description': 'Ultrasound imaging with Elastography will be performed at the inclusion (T0), after course 1 and course 2 respectively with anthracyclines, at the end of anthracycline treatment and at the end of taxane treatment.', 'armGroupLabels': ['3D Shear Wave Elastography (SWE)']}, {'name': 'Biopsy', 'type': 'BIOLOGICAL', 'description': 'Optional biopsy of breast tumor under neoadjuvant chemotherapy after the course 2 of anthracycline.', 'armGroupLabels': ['3D Shear Wave Elastography (SWE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.', 'ipdSharing': 'YES', 'description': 'Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.', 'accessCriteria': 'Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Curie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}