Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT03340402
Status:
WITHDRAWN
Last Update Posted:
2019-11-14
First Post:
2017-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Accelerated Partial Breast Irradiation for Triple Negative Breast Cancer Using Proton Beam Scanning
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Slow Accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-12', 'studyFirstSubmitDate': '2017-11-08', 'studyFirstSubmitQcDate': '2017-11-09', 'lastUpdatePostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative incidence of grade ≥ 3 acute dermatitis', 'timeFrame': '4 Months', 'description': 'The number of participants that experience grade 3 or greater acute dermatitis as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4).'}], 'secondaryOutcomes': [{'measure': 'The margins needed around Gross Tumor Volume (GTV)', 'timeFrame': '4 Months', 'description': 'Summary of the margins needed around gross tumor volume based on the true tumor location.'}, {'measure': 'Summary of treatment related adverse events', 'timeFrame': '2 years', 'description': 'Summary of the treatment related adverse events experienced by participants as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)'}, {'measure': 'Pathological response rate', 'timeFrame': '2 years', 'description': 'Evaluation of the extent of residual active tumor following radiation as assessed on the surgical pathology specimen'}, {'measure': 'Rates of local failure', 'timeFrame': '2 years', 'description': 'The number of participants with local recurrence of cancer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Breast Cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This research study is studying an intervention as a possible treatment for Triple Negative Breast Cancer.', 'detailedDescription': 'This research study is a Pilot Study, which means this is the first time investigators are examining this study intervention in participants with triple negative breast cancer.\n\nThe FDA (the U.S. Food and Drug Administration) has not approved proton radiation for your specific disease but it has been approved for other uses.\n\nThe investigators believe that proton radiation administered in higher doses over a shorter time period may help stop cancer from growing while protecting the normal tissue cells.\n\nIn this research study, the investigators are researching how well proton radiation works in treating this type of breast cancer. Proton radiation is currently used in other types of breast cancer and the investigators believe that the higher doses of proton radiation administered over a shorter time period may lead to maximum efficacy in treating this type of breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at least 40 years\n* Core biopsy proven estrogen negative (\\< 1%), progesterone negative (\\< 1%), and HER2-neu negative (+1 by immunohistochemistry and/or FISH ratio \\< 2.0) invasive breast cancer\n* Unicentric AJCC 7th edition T1N0M0 tumor measuring no greater than 2.0 cm in longest dimension on initial imaging with either breast MRI and/or mammogram\n* ECOG Performance status \\< 1\n* No prior treatment for this diagnosis of cancer\n* No prior radiation to the ipsilateral breast, a history of contralateral breast radiation is permitted\n* No clinical or radiographic evidence of malignant regional adenopathy\n* No contraindication to breast conserving surgery, sentinel lymph node biopsy, or radiation therapy\n* Ability to understand and willingness to sign a written informed consent document.\n* Pregnant females are excluded. Female subjects of childbearing potential must indicate to their physician that there is not a possibility of being pregnant at the time of enrollment or have a negative pregnancy test prior to initiation of radiation therapy\n\nExclusion Criteria:\n\n* Multicentric breast cancer, defined as discontiguous tumors separated by at least 5 cm of uninvolved tissue or discontiguous tumors that are located within separate breast quadrants either clinical or mammographically.\n* Multifocal breast cancer, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5 cm, or within the same breast quadrant.\n* Tumor \\> 2.0 cm, nodal involvement, or metastatic involvement\n* Patients with either diffuse (\\>1 quadrant or \\> 5 cm) suspicious microcalcifications on mammogram or diffuse non-mass-like enhancement on MRI\n* History of ipsilateral cosmetic or reconstructive breast surgery\n* Patients with a pacemaker or defibrillator\n* Any contraindication to MRI including but not limited to the presence of a pacemaker/defibrillator or other implanted ferromagnetic device or an inability to lie prone\n* Pregnant or lactating women\n* Medical condition including but not limited to ongoing or active infection or connective tissue disease (e.g. systemic sclerosis or other collagen vascular diseases) that would, in the opinion of the treating physician, make this protocol unreasonably hazardous to the patient.\n* Psychiatric illness/social situation that would limit ability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03340402', 'briefTitle': 'Preoperative Accelerated Partial Breast Irradiation for Triple Negative Breast Cancer Using Proton Beam Scanning', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Pilot Study of Preoperative Accelerated Partial Breast Irradiation for Triple Negative Breast Cancer Using Proton Beam Scanning', 'orgStudyIdInfo': {'id': '17-416'}, 'secondaryIdInfos': [{'id': '208901', 'type': 'OTHER', 'domain': 'Federal Share Core'}, {'id': '2U19CA021239', 'link': 'https://reporter.nih.gov/quickSearch/2U19CA021239', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Accelerated Partial Breast Irradiation', 'description': 'Accelerated partial breast irradiation using proton beam scanning will consist of;\n\n* 5 daily treatments using custom prone patient immobilization, contrast-enhanced CT planning, and daily image guidance\n* Radiation therapy may be delivered with photons if proton treatments cannot be delivered\n* Dose will be prescribed such that the gross tumor (GTV) receives the prescription dose per institutional policy and standard of care\n* Daily target localization will also be confirmed using AlignRTTM', 'interventionNames': ['Radiation: Accelerated Partial Breast Irradiation', 'Device: AlignRT']}], 'interventions': [{'name': 'Accelerated Partial Breast Irradiation', 'type': 'RADIATION', 'description': 'Proton radiation', 'armGroupLabels': ['Accelerated Partial Breast Irradiation']}, {'name': 'AlignRT', 'type': 'DEVICE', 'description': "AlignRTTM uses infrared imaging to capture the 3D data of the patient's position to ensure accuracy of treatment delivery", 'armGroupLabels': ['Accelerated Partial Breast Irradiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Rachel B Jimenez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal Share Core', 'class': 'UNKNOWN'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rachel Beth Jimenez', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}