Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-03-03 @ 3:05 PM
Study NCT ID:
NCT00093002
Status:
COMPLETED
Last Update Posted:
2008-06-12
First Post:
2004-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive 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': 'D000077267', 'term': 'Fulvestrant'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-11', 'studyFirstSubmitDate': '2004-09-28', 'studyFirstSubmitQcDate': '2004-09-28', 'lastUpdatePostDateStruct': {'date': '2008-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-09-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-proliferative effect after 4 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Safety, tolerability, tumor response and pharmacokinetics after 4 weeks of treatment.'}]}, 'conditionsModule': {'keywords': ['Early Breast Cancer', 'neoadjuvant therapy', 'hormonal treatment', 'newly diagnosed breast cancer', 'Estrogen Receptor Positive Breast Cancer', 'treatment naïve', 'neoadjuvant treatment', 'neoadjuvant setting', 'invasive breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nlm.nih.gov/medlineplus/breastcancer.html', 'label': 'Medline Plus - Information on Breast Cancer'}, {'url': 'http://www.breastcancer.org/', 'label': 'Breastcancer.org'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women defined as women who have stopped having menstrual periods\n* Written informed consent to participate in the trial\n* Biopsy confirmation of invasive breast cancer\n* Evidence of hormone sensitivity\n* Willingness to undergo biopsies\n\nExclusion Criteria:\n\n* Any previous treatment for breast cancer\n* Unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.\n* Any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus\n* The presence of more than one primary tumor\n* History of hypersensitivity to castor oil\n* History of known bleeding disorders'}, 'identificationModule': {'nctId': 'NCT00093002', 'briefTitle': 'Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Open-Label, Multicenter, Phase II Study Comparing the Effects on Proliferation and the Efficacy and Tolerability of Fulvestrant (FASLODEX®) 500 mg With Fulvestrant (FASLODEX®) 250 mg When Given as Neoadjuvant Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer (T2, 3, 4b, N0-3, M0).', 'orgStudyIdInfo': {'id': '9238IL/0065'}, 'secondaryIdInfos': [{'id': 'D6997C00003'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '250 mg fulvestrant', 'interventionNames': ['Drug: Fulvestrant']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '500 mg fulvestrant', 'interventionNames': ['Drug: Fulvestrant']}], 'interventions': [{'name': 'Fulvestrant', 'type': 'DRUG', 'otherNames': ['FASLODEX™', 'ZD9238'], 'description': '250 mg \\& 500 mg intramuscular injection', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Winchester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.45232, 'lon': -71.137}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Laredo', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.50641, 'lon': -99.50754}}, {'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Salzburg', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Barretos', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}, {'city': 'Florianópolis', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -27.59667, 'lon': -48.54917}}, {'city': 'Goiamia', 'country': 'Brazil', 'facility': 'Research Site'}, {'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Santo André', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'city': 'München', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Rostock', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Hyderabaad', 'country': 'India', 'facility': 'Research Site'}, {'city': 'New Delhi', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'city': 'Pune', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Trivandrum', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 8.4855, 'lon': 76.94924}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'AstraZeneca Faslodex Medical Science Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}