Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 1:37 PM
Study NCT ID:
NCT04118192
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-24
First Post:
2019-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NOSTRA-Feasibility Study: A Study Looking at Ultrasound Guided Biopsies for 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumour bed core biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2019-09-05', 'studyFirstSubmitQcDate': '2019-10-03', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observed number of patients with false negative biopsies', 'timeFrame': '12 months post last patient recruited', 'description': 'The observed number of patients with false negative biopsies (i.e. no tumour in the biopsy but tumour in the surgical specimen) as a proportion of all those assessed by Local Histopathology Review.'}], 'secondaryOutcomes': [{'measure': 'Concordance between Local and Central Histopathology Review of core biopsies', 'timeFrame': '12 months post last patient recruited', 'description': 'The number of patients whose initial local pathological assessment of pCR is confirmed by Central Histopathology Review.'}, {'measure': 'Compliance with treatment', 'timeFrame': '12 months post last patient recruited', 'description': 'Assessed by calculating relative dose intensity taking into account both reductions in dose and delays to treatment.'}, {'measure': 'Time to local recurrence', 'timeFrame': 'Number of days from registration to local recurrence (if within trial duration, approximately 1.5 years)', 'description': 'Defined in whole days from date of registration to local recurrence or death from any cause. Patients who are alive and without local recurrence at the time of analysis will be censored at the date last seen.'}, {'measure': 'Time to distant recurrence', 'timeFrame': 'Number of days from registration to distant recurrence (if within trial duration, approximately 1.5 years)', 'description': 'Defined in whole days from date of registration to distant recurrence or death from any cause. Patients who are alive and without distant recurrence at the time of analysis will be censored at the date last known to be alive.'}, {'measure': 'Overall survival', 'timeFrame': 'Whole days from registration to death from any cause (if within trial duration, approximately 1.5 years)', 'description': 'Defined in whole days as the date of registration to death from any cause. Patients alive at the time of analysis will be censored at the date last seen.'}, {'measure': 'Re-evaluation of the primary outcome using the Central Pathological Review determination of RCB to define false negative biopsies as RCB-0 or 1 (i.e. no tumour or minimal residual disease) in the core biopsies but RCB-2 or 3 in the surgical specimen', 'timeFrame': 'Post-last patient last surgery (within approximately 1.5 years of start of trial)', 'description': 'This will be reported as a proportion of all recruited patients.'}, {'measure': 'Ability of the axillary lymph node assessments post-neoadjuvant treatment to identify definitive axillary lymph node involvement determined by surgery histopathology', 'timeFrame': 'Post-last patient last surgery (within approximately 1.5 years of start of trial)', 'description': 'Sensitivity, specificity and false negative rates will be reported.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'HER2 positive', 'ER negative', 'Tumour bed core biopsies'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'A prospective non-randomised multi-centre feasibility study to assess if patients with residual cancer following dual-targeted neoadjuvant chemotherapy treatment for HER2-positive, ER-negative early breast cancer can be identified by multiple ultrasound (US)-guided tumour bed core biopsies', 'detailedDescription': 'The NOSTRA-Feasibility study is designed to determine if it is safe to omit surgery after the planned neoadjuvant chemotherapy plus dual-targeted anti-HER2 treatment. The study is needed to determine whether patients with residual cancer can be identified by histological examination of multiple ultrasound-guided tumour bed core biopsies following dual-targeted neoadjuvant treatment for HER2-positive, ER-negative early primary breast cancer and whether there is concordance between local pathology reporting and central pathology reporting by the trials expert pathologists.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'HER-2 positive ER-negative breast cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with histological diagnosis of operable HER2-positive, ER-negative, early stage invasive breast cancer\n* Tumour size ≥ 1cm and visible on US (T1c to T4d)\n* Patient fit and willing to receive, or is already receiving and has received no more than five cycles of a NOSTRA-Feasibility Study approved treatment regimen, in the opinion of the responsible clinician\n* Eastern Co-operative Group (ECOG) performance status of 0 or 1\n* Women of child-bearing potential, prepared to adopt highly effective contraceptive measures if sexually active for at least 6 months after completion of study medication\n* Female, 18 years or older\n* Able to provide informed consent for the study\n* Availability of embedded paraffin tumour blocks from pre-chemotherapy biopsy\n* The radiology team are able and willing to perform the tumour bed core biopsies\n\nExclusion Criteria:\n\n* Previous ipsilateral invasive breast cancer or Ductal Carcinoma in Situ (DCIS)\n* Unequivocal evidence of distant metastatic disease at registration\n* Multi-focal disease at diagnosis\n* Active malignancy\n* Previous chemotherapy\n* Prior extensive radiotherapy (as judged by the Investigator) to bone marrow\n* Risk factors precluding the safe administration of the intended cytotoxic chemotherapy regimen\n* Patient unsuitable for the planned dual-targeted anti-HER2 treatment in opinion of the Investigator\n* Prior diagnosis of cardiac failure\n* Uncontrolled hypertension, coronary heart disease or other significant cardiac abnormality\n* Bleeding diathesis\n* Any evidence of other disease which in the opinion of the Investigator places the patient at high risk of treatment related complications\n* Pregnant (female patients of child bearing potential must have a urine or blood Human Chorionic Gonadotropin test performed to rule out pregnancy prior to study entry)\n* Patient lactating\n* Patients who have received live vaccine within 4 weeks of the date of study entry\n* Any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment or follow-up\n* Patient unfit and/or unwilling to undergo surgery\n* Patient unwilling or unable to comply with scheduled visits, treatment plan and study procedures\n* Patient has started protocol non-compliant neo-adjuvant chemotherapy\n* Patient has started approved neoadjuvant chemotherapy but insufficient data is available to complete relevant CRFs\n* Patient has already received more than five cycles of approved neoadjuvant chemotherapy\n\nAdditional Inclusion Criteria for ctDNA Sub-Study\n\n* Patient has not yet started neoadjuvant treatment\n* Patient is willing and able to give blood samples as per ctDNA Sub-Study Guidelines'}, 'identificationModule': {'nctId': 'NCT04118192', 'acronym': 'NOSTRA', 'briefTitle': 'NOSTRA-Feasibility Study: A Study Looking at Ultrasound Guided Biopsies for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Birmingham'}, 'officialTitle': 'Can Patients With Residual Cancer After Chemotherapy for Early Breast Cancer be Identified With Multiple Ultrasound-guided Biopsies?', 'orgStudyIdInfo': {'id': 'RG_16-108'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tumour bed core biopsy', 'type': 'PROCEDURE', 'description': 'Collection of up to 8 core biopsies across 4 zones of the whole tumour bed to detect residual cancer post neo-adjuvant treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SS16 5NL', 'city': 'Basildon', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Basildon Hospital', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Belfast City Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'B18 7QH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'City Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'FY3 8NR', 'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Blackpool Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'zip': 'BS10 5NB', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Southmead Hospital', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CF64 2XX', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Hospital of Llandough', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'GL53 7AN', 'city': 'Cheltenham', 'country': 'United Kingdom', 'facility': 'Cheltenham General Hospital', 'geoPoint': {'lat': 51.90006, 'lon': -2.07972}}, {'city': 'Dumfries', 'country': 'United Kingdom', 'facility': 'Dumfries and Galloway Royal Infirmary', 'geoPoint': {'lat': 55.06959, 'lon': -3.61139}}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Western General', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'HA1 3UJ', 'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'Northwick Park Hospital', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': "St James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Royal Liverpool Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'SW3 6JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'TD6 9BS', 'city': 'Melrose', 'country': 'United Kingdom', 'facility': 'Borders General Hospital', 'geoPoint': {'lat': 55.59969, 'lon': -2.7277}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Royal Victoria Infirmary', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham City Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'PE3 9GZ', 'city': 'Peterborough', 'country': 'United Kingdom', 'facility': 'Peterborough City Hospital', 'geoPoint': {'lat': 52.57364, 'lon': -0.24777}}, {'zip': 'BH15 2JB', 'city': 'Poole', 'country': 'United Kingdom', 'facility': 'Poole Hospital', 'geoPoint': {'lat': 50.71429, 'lon': -1.98458}}, {'zip': 'S10 2SJ', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Weston Park Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'city': 'Swansea', 'country': 'United Kingdom', 'facility': 'Singleton Hospital', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}, {'zip': 'CH49 5PE', 'city': 'Upton', 'country': 'United Kingdom', 'facility': 'Arrowe Park Hospital', 'geoPoint': {'lat': 53.61466, 'lon': -1.28677}}, {'zip': 'WN1 1RU', 'city': 'Wigan', 'country': 'United Kingdom', 'facility': 'Thomas Linacre Centre', 'geoPoint': {'lat': 53.54296, 'lon': -2.63706}}], 'overallOfficials': [{'name': 'Daniel Rea', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}, {'name': 'Cancer Research UK', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}