Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT00944918
Status:
COMPLETED
Last Update Posted:
2011-08-29
First Post:
2009-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)
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': 'D000077267', 'term': 'Fulvestrant'}, {'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'C056516', 'term': 'exemestane'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-26', 'studyFirstSubmitDate': '2009-07-22', 'studyFirstSubmitQcDate': '2009-07-22', 'lastUpdatePostDateStruct': {'date': '2011-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'every 3 months during treatment and, at time of discontinuation from treatment'}], 'secondaryOutcomes': [{'measure': 'Objective complete response (CR) and partial response (PR) rate', 'timeFrame': 'every 3 months during treatment and, at time of discontinuation from treatment'}, {'measure': 'Duration of response', 'timeFrame': 'every 3 months during treatment and, at time of discontinuation from treatment'}, {'measure': 'Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate', 'timeFrame': 'every 3 months during treatment and, at time of discontinuation from treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast Cancer'], 'conditions': ['Progression-free Survival']}, 'referencesModule': {'references': [{'pmid': '23902874', 'type': 'DERIVED', 'citation': 'Johnston SR, Kilburn LS, Ellis P, Dodwell D, Cameron D, Hayward L, Im YH, Braybrooke JP, Brunt AM, Cheung KL, Jyothirmayi R, Robinson A, Wardley AM, Wheatley D, Howell A, Coombes G, Sergenson N, Sin HJ, Folkerd E, Dowsett M, Bliss JM; SoFEA investigators. Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Lancet Oncol. 2013 Sep;14(10):989-98. doi: 10.1016/S1470-2045(13)70322-X. Epub 2013 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs. Randomisation to Faslodex ± Arimidex / Arimidex-Placebo or exemestane will be open (1:1:1). For Faslodex treated patients the randomisation to Arimidex or Arimidex-Placebo will be double-blind.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the breast.\n* Metastatic disease must be measurable or evaluable\n* Relapsed or progressed during prior treatment with single-agent NSAI, meeting either of the following criteria:\n* NSAI given as adjuvant therapy that lasted ≥ 12 months OR\n* Achieved an objective CR, PR, or SD that that lasted ≥ 6 months after prior 1st-line\n* Female postmenopausal patients\n\nExclusion Criteria:\n\n* Hormone receptor status1. ER -ve and PgR NK2. ER-ve and PgR -ve3. ER NK\n* Prescribed Tamoxifen for metastatic disease\n* Rapidly progressive visceral disease\n* Patients with malignancies within the last 5 years.'}, 'identificationModule': {'nctId': 'NCT00944918', 'briefTitle': 'Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Partially-blind Phase III Randomised Trial of Fulvestrant (Faslodex) With or Without Concomitant Anastrozole (Arimidex) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-steroidal Aromatase Inhibitors', 'orgStudyIdInfo': {'id': '9238UK/0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'fulvestrant and anastrozole', 'interventionNames': ['Drug: fulvestrant', 'Drug: anastrozole']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'fulvestrant and placebo', 'interventionNames': ['Drug: fulvestrant']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'exemestane alone', 'interventionNames': ['Drug: exemestane']}], 'interventions': [{'name': 'fulvestrant', 'type': 'DRUG', 'otherNames': ['Faslodex'], 'description': 'Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.', 'armGroupLabels': ['1', '2']}, {'name': 'anastrozole', 'type': 'DRUG', 'otherNames': ['Arimidex'], 'description': 'Tablet, oral, once daily until disease progression.', 'armGroupLabels': ['1']}, {'name': 'exemestane', 'type': 'DRUG', 'otherNames': ['Aromasin'], 'description': 'Tablet, oral, once daily until disease progression.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ilsan', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young-Huck Im', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor(Samsung Medical Center)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}