Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-27 @ 7:17 AM
Study NCT ID:
NCT00639366
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2008-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy to the Head in Preventing Brain Metastases in Women Receiving Trastuzumab and Chemotherapy for Metastatic or Locally Advanced 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2008-03-19', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of symptomatic brain metastases'}], 'secondaryOutcomes': [{'measure': 'Survival'}, {'measure': 'Cerebral toxicity and quality of life'}]}, 'conditionsModule': {'keywords': ['recurrent breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer', 'stage IV breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy directed at the head is effective in preventing brain metastases in patients with advanced cancer.\n\nPURPOSE: This randomized phase III trial is studying radiation therapy to the head to see how well it works in preventing brain metastases in women receiving trastuzumab and chemotherapy for metastatic or locally advanced breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* To test if prophylactic cranial radiotherapy delivering 30 Gy in 10 fractions will significantly reduce (from 35% to 21% at 2 years) the incidence of symptomatic brain metastases in patients treated with trastuzumab (Herceptin®) for metastatic breast cancer.\n\nOUTLINE: This is a multicenter study. Patients are stratified by center, type of systemic therapy (trastuzumab \\[Herceptin®\\] monotherapy vs combination with chemotherapy), hormone receptor status, and presence of lung metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive taxane/trastuzumab therapy for 6 weeks. While continuing taxane/trastuzumab therapy, patients then undergo 10 fractions of concurrent prophylactic cranial radiotherapy in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive taxane/trastuzumab therapy without concurrent prophylactic cranial radiotherapy.\n\nAll patients undergo quality of life assessments every 8 weeks for 9 months.\n\nAfter completion of study treatment, patients are followed periodically for at least 1 year.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven breast carcinoma\n\n * Metastatic or locally advanced disease\n* Must demonstrate HER2 3+ positivity on IHC or 2+ over-expression and FISH test demonstrating C-erB2 gene amplification\n* No known or suspected brain metastases or CNS disease, as defined by the presence of any of the following key symptoms:\n\n * Headache\n * Nausea and/or vomiting\n * Clinical signs of raised intracranial pressure\n * Seizures\n * Focal symptoms\n * Cognitive dysfunction\n * Affective disorder\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Female\n* Postmenopausal status not specified\n* ECOG performance status 0 or 1\n* Patients must a-priori be suitable for trastuzumab (Herceptin®) +/- chemotherapy in terms of bone marrow, hepatic, and renal function\n* No prior history of cerebrovascular disease or neurological disorder including seizures\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior cranial radiotherapy\n* No prior neurosurgery'}, 'identificationModule': {'nctId': 'NCT00639366', 'briefTitle': 'Radiation Therapy to the Head in Preventing Brain Metastases in Women Receiving Trastuzumab and Chemotherapy for Metastatic or Locally Advanced Breast Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Prospective Randomised Clinical Trial Testing the Role of Prophylactic Cranial Radiotherapy in Patients Treated With Trastuzumab (Herceptin®) for Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'ACCOG-HER-PCI'}, 'secondaryIdInfos': [{'id': 'CDR0000588868', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'ISRCTN64624715'}, {'id': 'EU-20822'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'trastuzumab', 'type': 'BIOLOGICAL'}, {'name': 'chemotherapy', 'type': 'DRUG'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SS16 5NL', 'city': 'Basildon', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Basildon University Hospital', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'zip': 'IP4 5PD', 'city': 'Ipswich', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Ipswich Hospital', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': "Leeds Cancer Centre at St. James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Liverpool University Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'L9 7AL', 'city': 'Liverpool', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Aintree University Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'EC1M 6BQ', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Barts and the London School of Medicine', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Christie Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'CH63 4JY', 'city': 'Merseyside', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Clatterbridge Centre for Oncology'}, {'zip': 'S1O 2SJ', 'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cancer Research Centre at Weston Park Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SN3 6BB', 'city': 'Swindon', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Great Western Hospital', 'geoPoint': {'lat': 51.55797, 'lon': -1.78116}}, {'zip': 'SS0 0RY', 'city': 'Westcliff-on-Sea', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Southend University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.54424, 'lon': 0.69179}}, {'zip': 'Y031 8HE', 'city': 'York', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cancer Care Centre at York Hospital', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}, {'zip': 'DG1 4AP', 'city': 'Dumfries', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Dumfries & Galloway Royal Infirmary', 'geoPoint': {'lat': 55.06959, 'lon': -3.61139}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Edinburgh Cancer Centre at Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'FK1 5QE', 'city': 'Falkirk', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Falkirk and District Royal Infirmary', 'geoPoint': {'lat': 56.0021, 'lon': -3.78535}}, {'zip': 'G12 0YN', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Beatson West of Scotland Cancer Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'KA2 OBE', 'city': 'Kilmarnock', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Crosshouse Hospital', 'geoPoint': {'lat': 55.61171, 'lon': -4.49581}}, {'zip': 'ML2 0DP', 'city': 'Wishaw', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Wishaw General Hospital', 'geoPoint': {'lat': 55.76667, 'lon': -3.91667}}], 'overallOfficials': [{'name': 'Peter A. Canney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Glasgow'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anglo Celtic Cooperative Oncology Group', 'class': 'OTHER'}}}}