Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-28 @ 12:24 AM
Study NCT ID:
NCT05673304
Status:
RECRUITING
Last Update Posted:
2024-12-18
First Post:
2023-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2023-01-04', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pCR', 'timeFrame': '6 month after SBRT (at surgery)', 'description': 'pathological complete response rate (according to AJCC-TNM and RCB) after SBRT anticipated boost'}], 'secondaryOutcomes': [{'measure': 'acute toxicity', 'timeFrame': 'immediate to 6 months after SBRT', 'description': 'acute toxicity after SBRT, evaluated according to CTCAE v.5'}, {'measure': 'late toxicity', 'timeFrame': 'from 6 months after SBRT', 'description': 'late toxicity after completion of treatments (included adjuvant RT), evaluated according to CTCAE v.5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Luminal B Breast Cancer', 'Neoadjuvant radiation therapy', 'Neoadjuvant chemotherapy'], 'conditions': ['Breast Cancer', 'Radiotherapy']}, 'descriptionModule': {'briefSummary': 'IBISCO TRIAL is a phase II trial aimed to demonstrate the improvement of pathological complete response (pCR) in Luminal B breast cancer (BC) patients treated with stereotactic radiation therapy (SBRT) as an anticipated boost associated with neoadjuvant chemotherapy (NAC).\n\nAs a secondary objective, histochemical and molecular analysis of the tumour and the inflammatory microenvironment will be performed.', 'detailedDescription': 'IBISCO TRIAL is a phase II trial aimed to demonstrate the improvement of pCR in Luminal B breast cancer (BC) patients treated with stereotactic radiation therapy (SBRT) as an anticipated boost associated with neoadjuvant chemotherapy (NAC).\n\nThe primary endpoint will be evaluated on surgical specimen using the residual cancer burden (RCB) index.\n\nThirty patients with clinical stage T1-2 Luminal B BC, suitable for conservative surgery and with a clinical indication for NAC, will be enrolled in two years. An observation cohort will also be created with patients fulfilling inclusion criteria who refuse enrollment in the interventional cohort and for patients where SBRT boost appears not feasible after enrollment for technical issues.\n\nAs a secondary objective, histochemical and molecular analysis of the tumour and the inflammatory microenvironment will be performed.\n\nAfter the completion of neoadjuvant treatments, surgery and adjuvant therapies (endocrine therapy and whole breast irradiation) will be performed as for clinical practice'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Luminal B-like BC, cT1-2\n* Indication for neoadjuvant chemotherapy\n\nExclusion Criteria:\n\n* Pregnancy\n* Breast feeding\n* Patient not available for follow up'}, 'identificationModule': {'nctId': 'NCT05673304', 'briefTitle': 'Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Immune and Pathological Response in Breast Cancer After Preoperative Irradiation With Stereotactic Technique and Neoadjuvant ChemOtherapy', 'orgStudyIdInfo': {'id': 'IBISCO Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': 'Patients will be treated on the primary tumour with a total dose of 24 Gy (8 Gy x 3 fractions QD) within 2 weeks from the start of neoadjuvant chemotherapy', 'interventionNames': ['Radiation: SBRT anticipated boost']}, {'type': 'NO_INTERVENTION', 'label': 'observational cohort', 'description': 'This cohort will include patients fulfilling inclusion criteria who refuse enrollment in the interventional cohort and patients where SBRT boost appears not feasible after enrollment for technical issues'}], 'interventions': [{'name': 'SBRT anticipated boost', 'type': 'RADIATION', 'description': '24 Gy in 3 fractions to the tumour', 'armGroupLabels': ['Interventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alice Zamagni, MD', 'role': 'CONTACT'}, {'name': 'Alessio G Morganti, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Alice Zamagni, MD', 'role': 'CONTACT', 'email': 'alice.zamagni4@unibo.it', 'phone': '+39 0512143564'}], 'overallOfficials': [{'name': 'Alessio G Morganti, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}