Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-15 @ 7:27 PM
Study NCT ID:
NCT06704659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-26
First Post:
2024-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Recurrent Breast Cancer and Repeated Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D008408', 'term': 'Mastectomy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-11-21', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A treatment-limiting radiation therapy complication.', 'timeFrame': 'From the beginning of the radiotherapy until 30 days after finishing the therapy', 'description': 'Any complication related to radiation therapy, that would limit completing the radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '5 years from surgery', 'description': 'Patients are asked to complete a quality of life questionnaire before the surgery and at 3 months, 1 year, 3 years, and 5 years after the surgery'}, {'measure': 'Second Breast Cancer Recurrence', 'timeFrame': '5 years from surgery', 'description': 'The patients are surveilled for second breast cancer recurrence'}, {'measure': 'Secondary malignancies', 'timeFrame': '5 years', 'description': 'The patients are surveilled for any other secondary malignancy than breast cancer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Recurrence', 'Repeat radiation therapy', 'Radiation therapy'], 'conditions': ['Recurrent Breast Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study explores whether recurrent breast cancer can be safely treated with breast-conserving surgery and repeated radiation therapy in cases where patients have previously undergone radiation. Traditionally, recurrent breast cancer has been treated by removing the entire breast. However, recent research has shown that in certain situations, it may be possible to preserve the breast.\n\nThe study will collect data on the safety of this treatment approach and its effects on patients. The treatment follows standard breast cancer care practices, involving 30 patients from Helsinki and Turku University Hospitals. Patients are carefully selected based on specific criteria, such as tumor size, localization, and prior treatment history. Special attention is given to the planning of radiation therapy and surgical techniques.\n\nThe goal is to develop new treatment strategies that allow breast preservation even in cases of recurrent breast cancer, providing patients with high-quality and individualized care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient has a diagnosed breast cancer or tumor area in the breast with a maximum diameter of 3 cm, where a previous breast-conserving surgery has been performed (either invasive breast cancer or carcinoma in situ, DCIS).\n\nThe patient has only a local recurrence, and imaging studies show no suspicion of metastases outside the breast (preoperative staging N0M0).\n\nAt least 3 years have passed since the completion of prior radiation therapy. The new breast cancer can be technically treated with another breast-conserving surgery using a technique that does not require tissue transfer from areas opposite the removed tumor to restore the shape of the breast.\n\nThe patient is at least 55 years old at the time of surgery. The patient is willing to participate in the study. The patient is capable of providing informed consent.\n\nExclusion Criteria:\n\n* A booster dose, also known as a "boost," was administered during prior radiation therapy.\n\nPreoperative assessments suggest multifocal breast cancer, with the tumor area to be removed exceeding 3 cm.\n\nThe planned radiation therapy per the study protocol cannot be administered due to factors such as shoulder joint stiffness, a pacemaker located in the radiation field, or a skin condition (e.g., scleroderma).\n\nThe patient is unable to provide informed consent or is unwilling to participate in the study.\n\nMetastases outside the breast (e.g., axillary or distant metastases) are present.'}, 'identificationModule': {'nctId': 'NCT06704659', 'acronym': 'RAY-no-BAN', 'briefTitle': 'Study on Recurrent Breast Cancer and Repeated Radiation Therapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Study on Recurrent Breast Cancer and Repeated Radiation Therapy', 'orgStudyIdInfo': {'id': 'T1641/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Repeat breast conserving surgery and radiotherapy Arm', 'description': 'The patients in this arm undergo repeat breast conserving surgery and partial breast radiotherapy', 'interventionNames': ['Radiation: Breast conserving surgey and radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mastectomy Arm', 'description': 'The patients in this arm undergo mastectomy', 'interventionNames': ['Procedure: Mastectomy']}], 'interventions': [{'name': 'Breast conserving surgey and radiotherapy', 'type': 'RADIATION', 'description': 'The patients will undergo repeat Breast Conserving Surgery and Radiotherapy', 'armGroupLabels': ['Repeat breast conserving surgery and radiotherapy Arm']}, {'name': 'Mastectomy', 'type': 'PROCEDURE', 'description': 'The patients will undergo mastectomy', 'armGroupLabels': ['Mastectomy Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'contacts': [{'name': 'Tuomo Meretoja, MD, PhD', 'role': 'CONTACT', 'email': 'tuomo.meretoja@hus.fi', 'phone': '+358504272 877'}], 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Turku', 'country': 'Finland', 'contacts': [{'name': 'Anselm Tamminen, MD, PhD', 'role': 'CONTACT', 'email': 'jlatam@utu.fi'}], 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'centralContacts': [{'name': 'Anselm Tamminen, MD, PhD', 'role': 'CONTACT', 'email': 'jlatam@utu.fi', 'phone': '+3583130000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Helsinki University Hospital, Finland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}