Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-29 @ 5:57 AM
Study NCT ID:
NCT00077168
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2004-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Radiation Therapy Compared With Observation After Surgery in Treating Women With Estrogen Receptor Positive or Progesterone Receptor Positive Ductal Carcinoma In Situ of the Breast Who Are Receiving Tamoxifen or Anastrozole
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}], '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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'lastUpdateSubmitDate': '2009-02-06', 'studyFirstSubmitDate': '2004-02-10', 'studyFirstSubmitQcDate': '2004-02-10', 'lastUpdatePostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local tumor control (invasive and in situ local recurrence)'}], 'secondaryOutcomes': [{'measure': 'Mastectomy rate'}, {'measure': 'Pattern of relapse in the breast'}, {'measure': 'Contralateral primary'}, {'measure': 'Breast cancer metastases'}, {'measure': 'Mortality'}, {'measure': 'Quality of life'}, {'measure': 'Molecular markers that predict ipsilateral tumor recurrence'}]}, 'conditionsModule': {'keywords': ['ductal breast carcinoma in situ', 'breast cancer in situ'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy after surgery is effective in preventing a recurrence of ductal carcinoma in situ.\n\nPURPOSE: This randomized phase II trial is studying adjuvant radiation therapy to see how well it works compared to observation after surgery in treating women with estrogen receptor positive or progesterone receptor positive ductal carcinoma in situ and are also receiving either tamoxifen or anastrozole.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare ipsilateral tumor relapse and breast cancer metastases in women with completely excised low-risk estrogen receptor- or progesterone receptor-positive ductal carcinoma in situ of the breast receiving adjuvant tamoxifen or anastrozole and treated with adjuvant radiotherapy vs observation alone.\n* Compare the quality of life of patients treated with these regimens.\n\nSecondary\n\n* Determine the minimal surgical margins required to minimize the local recurrence rate in patients treated with these regimens.\n* Identify molecular markers that predict ipsilateral tumor recurrence in patients treated with these regimens.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.\n\nAll patients receive adjuvant tamoxifen or anastrozole for 5 years.\n\n* Arm I: Patients undergo radiotherapy 5 days a week for 3 or 5 weeks.\n* Arm II: Patients undergo observation alone. Quality of life is assessed at baseline, at 6 months, and then at 1, 2, and 5 years.\n\nPatients are followed every 6 months for 1 year and then annually for up to 10 years.\n\nPeer Reviewed and Funded or Endorsed by Cancer Research UK\n\nPROJECTED ACCRUAL: A total of 2,000 patients (1,000 per treatment arm) will be accrued for this study within 5 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of unifocal ductal carcinoma in situ of the breast without an invasive component\n\n * Microinvasion (defined as 1 or more foci of invasion each \\< 1 mm) allowed\n* Prior complete microscopic excision (within the past 6 months) with a minimum radial margin of 1 mm by specimen x-ray required\n* Maximum microscopic tumor diameter \\< 30 mm (\\< 15 mm if grade 3 tumor)\n* Planning to receive adjuvant tamoxifen or anastrozole for 5 years\n\n * Eligible patients may receive adjuvant endocrine therapy on ICR-IBIS-II\n* Hormone receptor status:\n\n * Estrogen receptor positive OR\n * Progesterone receptor positive\n * More than 10% tumor staining for receptor OR a cutpoint of ≥ 2\n\nPATIENT CHARACTERISTICS:\n\nSex\n\n* Female\n\nMenopausal status\n\n* Premenopausal, perimenopausal, or postmenopausal\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nCardiovascular\n\n* No prior deep vein thrombosis\n\nPulmonary\n\n* No prior pulmonary embolus\n\nOther\n\n* No unexplained postmenopausal bleeding\n* No contraindication to full-dose radiotherapy to the breast\n* No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* See Disease Characteristics\n* No prior tamoxifen or raloxifene use for more than 3 months in duration\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* See Disease Characteristics\n* No prior mastectomy\n\nOther\n\n* No concurrent anticoagulants'}, 'identificationModule': {'nctId': 'NCT00077168', 'briefTitle': 'Adjuvant Radiation Therapy Compared With Observation After Surgery in Treating Women With Estrogen Receptor Positive or Progesterone Receptor Positive Ductal Carcinoma In Situ of the Breast Who Are Receiving Tamoxifen or Anastrozole', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Randomised Trial Testing Observation (No Radiotherapy) Against Radiotherapy In Women With Low-Risk Completely Excised ER Positive Ductal Carcinoma In Situ (DCIS) Of The Breast On Adjuvant Endocrine Therapy', 'orgStudyIdInfo': {'id': 'CDR0000349580'}, 'secondaryIdInfos': [{'id': 'ICR-DCIS-II'}, {'id': 'EU-20341'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'anastrozole', 'type': 'DRUG'}, {'name': 'tamoxifen citrate', 'type': 'DRUG'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BS16 1LE', 'city': 'Bristol', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Frenchay Hospital at North Bristol NHS Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'BS2 8ED', 'city': 'Bristol', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Bristol Haematology and Oncology Centre', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CM1 7ET', 'city': 'Broomefield', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Broomfield Hospital'}, {'zip': 'CM2 0QH', 'city': 'Chelmsford', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Chelmsford and Essex Centre', 'geoPoint': {'lat': 51.73575, 'lon': 0.46958}}, {'zip': 'C03 3NB', 'city': 'Colchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Essex County Hospital', 'geoPoint': {'lat': 51.88921, 'lon': 0.90421}}, {'zip': 'DE1 2QY', 'city': 'Derby', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Derbyshire Royal Infirmary', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'DE1 2QY', 'city': 'Derby', 'state': 'England', 'country': 'United Kingdom', 'facility': "Queen's Hospital", 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'DT1 2JY', 'city': 'Dorchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Dorset County Hospital', 'geoPoint': {'lat': 50.71667, 'lon': -2.43333}}, {'zip': 'GU2 7XX', 'city': 'Guildford', 'state': 'England', 'country': 'United Kingdom', 'facility': "St. Luke's Cancer Centre at Royal Surrey County Hospital", 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'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': 'LN2 5QY', 'city': 'Lincoln', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Lincoln County Hospital', 'geoPoint': {'lat': 53.22683, 'lon': -0.53792}}, {'zip': 'W6 8RF', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Charing Cross Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M23 9LT', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'South Manchester University Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'CH63 4JY', 'city': 'Merseyside', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Clatterbridge Centre for Oncology NHS Trust'}, {'zip': 'MK6 5LD', 'city': 'Milton Keynes', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Milton Keynes General Hospital', 'geoPoint': {'lat': 52.04172, 'lon': -0.75583}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'BH15 2JB', 'city': 'Poole Dorset', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Poole Hospital NHS Trust'}, {'zip': 'RG1 5AN', 'city': 'Reading', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Berkshire Cancer Centre at Royal Berkshire Hospital', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'zip': 'YO12 6QL', 'city': 'Scarborough', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Scarborough General Hospital', 'geoPoint': {'lat': 54.27966, 'lon': -0.40443}}, {'zip': 'TS19 8PE', 'city': 'Stockton-on-Tees', 'state': 'England', 'country': 'United Kingdom', 'facility': 'University Hospital of North Tees', 'geoPoint': {'lat': 54.56848, 'lon': -1.3187}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Foundation Trust - Surrey', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'TQ2 7AA', 'city': 'Torquay Devon', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Torbay Hospital'}, {'zip': 'UB8 3NN', 'city': 'Uxbridge', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Hillingdon Hospital', 'geoPoint': {'lat': 51.5489, 'lon': -0.48211}}, {'zip': 'WR5 1DD', 'city': 'Worcester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Worcester Royal Hospital', 'geoPoint': {'lat': 52.18935, 'lon': -2.22001}}, {'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary at NHS Grampian', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'G11 6NT', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'University of Glasgow', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'LL57 2PW', 'city': 'Bangor', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Ysbyty Gwynedd', 'geoPoint': {'lat': 53.22752, 'lon': -4.12936}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'overallOfficials': [{'name': 'Ronald Kaggwa', 'affiliation': 'Institute of Cancer Research, United Kingdom'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Cancer Research, United Kingdom', 'class': 'OTHER'}}}}