Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT03981705
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2019-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-23', 'studyFirstSubmitDate': '2019-06-07', 'studyFirstSubmitQcDate': '2019-06-07', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Pathologic Response (pCR)', 'timeFrame': '6 Months Post Surgery', 'description': 'The primary aim of this feasibility study is to determine whether breast imaging with or without core needle biopsy after neoadjuvant chemotherapy (NAC) can accurately predict complete pathologic response (pCR) in women with biopsyproven triple negative or HER2+ breast cancer.'}], 'secondaryOutcomes': [{'measure': 'Complications and Side Effects of the Needle Biopsy Procedure after NAC', 'timeFrame': '6 Months Post Surgery', 'description': 'Incidence of Adverse Events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer'], 'conditions': ['TN ER-/PR-/HER2- Breast Cancer', 'Triple Negative Breast Cancer', 'HER2-positive Breast Cancer', 'ERany/PRany/HER2+ Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a feasibility study to gain preliminary information regarding whether breast imaging with or without a core needle biopsy after neoadjuvant chemotherapy (NAC) but before surgery can accurately predict complete pathologic response (pCR) in women with triple negative or HER2- positive breast cancer. pCR is defined as having no residual invasive breast cancer or ductal carcinoma in situ.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study entry is open to women 18 years of age and older regardless of race or ethnic background. While there will be every effort to seek out and include minority patients, the patient population is expected reflect those at the University of Minnesota with triple negative or HER2+ breast cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Biopsy proven triple negative (TN) (ER-/PR-/HER2-) or HER2 positive (ERany/PRany/HER2+) breast cancer for which neoadjuvant chemotherapy is planned\n* A biopsy clip placed at the time of diagnostic biopsy\n* 18 years of age or older\n* Must be able to read and write in English due to the importance of survey (questionnaire) completion to meet the study's endpoint - this is justified as there is no individual benefit to study participation\n* Able to provide written consent prior to any research related activities\n\nExclusion Criteria:\n\n* Stage IV breast cancer\n* T4 breast cancer\n* Previous ipsilateral breast cancer\n* Any contraindication for undergoing a contrast-enhanced breast MRI and/or the breast biopsy between chemotherapy and surgery"}, 'identificationModule': {'nctId': 'NCT03981705', 'briefTitle': 'Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'officialTitle': 'Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer', 'orgStudyIdInfo': {'id': '2018NTLS176'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Standard Trimodality Breast Imaging', 'type': 'RADIATION', 'description': 'Standard breast imaging with or without core needle biopsy after neoadjuvant chemotherapy (NAC).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Masonic Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Todd Tuttle, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}