Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT06631066
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2024-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Neoadjuvant Chemoradiation on Pathologic Complete Response Rates in Locally Advanced Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-06', 'studyFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2024-10-06', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pathologic complete response rates', 'timeFrame': '1 week postoperative', 'description': 'the pathologic response will be measured by the Randomized cancer burden (RCB) scoring system'}], 'secondaryOutcomes': [{'measure': 'acute radiation toxicity', 'timeFrame': 'during radiation therapy: week 2,3,4. weekly after the end of radiation therapy for 4 weeks', 'description': 'radiation therapy oncology group (RTOG) acute morbidity score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preoperative radiotherapy', 'locally advanced breast cancer', 'pathologic response'], 'conditions': ['Breast Cancer Female']}, 'referencesModule': {'references': [{'pmid': '39106546', 'type': 'BACKGROUND', 'citation': 'Ward J, Ho K, Ike C, Wood SH, Thiruchelvam PTR, Khan AA, Leff DR. Pre-operative chemoradiotherapy followed by mastectomy and breast reconstruction-A systematic review of clinical, oncological, reconstructive and aesthetic outcomes. J Plast Reconstr Aesthet Surg. 2024 Sep;96:242-253. doi: 10.1016/j.bjps.2024.07.022. Epub 2024 Jul 15.'}, {'pmid': '29948462', 'type': 'BACKGROUND', 'citation': "O' Halloran N, McVeigh T, Martin J, Keane M, Lowery A, Kerin M. Neoadjuvant chemoradiation and breast reconstruction: the potential for improved outcomes in the treatment of breast cancer. Ir J Med Sci. 2019 Feb;188(1):75-83. doi: 10.1007/s11845-018-1846-6. Epub 2018 Jun 14."}]}, 'descriptionModule': {'briefSummary': 'This is a phase II randomized trial comparing pathologic complete response rates in locally advanced patients recieving either neoadjuvant chemotherapy or neoadjuvant chemoradiation.', 'detailedDescription': 'A prospective randomized phase II trial, that enrolled locally advanced breast cancer patients who were randomized to recieve either neoadjuvant systemic treatment or neoadjuvant systemic treatment concurrently with radiotherapy. Surgery is done for all patients later on as indicated.\n\nThe pathological response rates between both groups will be compared, as well as surgical complications and acute radiation toxicity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patients.\n2. Age: 21 years or older.\n3. ECOG performance status (PS) score 0 to 2.\n4. Locally advanced tumors (stage IIIA or above) of any subtype.\n5. Early breast cancer of the HER2+ or TNBC subtype when:\n\n 1. Node-negative, T2 or T3.\n 2. Node-positive, any T stage.\n\nExclusion Criteria:\n\n1. Patients initially presenting with metastatic breast cancer.\n2. Patients unfit to receive planned regimen of treatment that had a poor PS (i.e.: PS 3 and 4).\n3. Inflammatory breast cancer (T4d) patients.\n4. Patients having contraindications to radiotherapy (e.g.: Pregnancy, history of previous chest wall, breast, or axillary irradiation)\n5. History of previous ipsilateral breast surgery.\n6. Comorbidities that would affect skin healing or integrity, like uncontrolled diabetes mellitus or active autoimmune collagen or vascular diseases'}, 'identificationModule': {'nctId': 'NCT06631066', 'briefTitle': 'Effect of Neoadjuvant Chemoradiation on Pathologic Complete Response Rates in Locally Advanced Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Effect of Neoadjuvant Chemoradiation on Pathologic Complete Response Rates in Locally Advanced Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'RO2109-30909'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'neoadjuvant chemotherapy arm', 'description': 'The patients in this arm will recieve neoadjuvant chemotherapy (with anti-her2 agents if indicated) according to the national guidelines.\n\npost systemic treatment imaging will be done to assess the response, followed by surgery as indicated.\n\nAdjuvant radiotherapy as well as hormonal or target therapy will be prescribed as indicated.\n\nRadiation therapy will be delivered in hypofractionated course (40.05 Gray over 15 fractions with boost to tumor bed 10 Gray over four fractions) to the breast/ chestwall as well as regional lymphatics.'}, {'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant chemoradiation arm', 'description': 'The patients in this arm will recieve neoadjuvant chemotherapy with preoperative radiotherapy concurrently with taxanes. Surgery is done 6-8 weeks as indicated, followed by systemic treatment according to the guidelines.', 'interventionNames': ['Radiation: neoadjuvant chemoradiation']}], 'interventions': [{'name': 'neoadjuvant chemoradiation', 'type': 'RADIATION', 'description': 'Neoadjuvant chemoradiation will be prescribed as: 4 cycles of Adriamycin and Cyclophosphamide followed by radiotherapy concurrently with taxanes/ taxanes and carboplatin. followed by surgery as indicated.', 'armGroupLabels': ['Neoadjuvant chemoradiation arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Medhat El Sebaie, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Marwa Mohammmed sayed', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}