Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT00234403
Status:
COMPLETED
Last Update Posted:
2009-04-23
First Post:
2005-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic 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': 'D000077156', 'term': 'Gefitinib'}, {'id': 'D000077267', 'term': 'Fulvestrant'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-22', 'studyFirstSubmitDate': '2005-10-05', 'studyFirstSubmitQcDate': '2005-10-05', 'lastUpdatePostDateStruct': {'date': '2009-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the progression-free survival (PFS) of the combination of 250 mg ZD1839 and fulvestrant in patients with advanced or metastatic breast cancer'}], 'secondaryOutcomes': [{'measure': 'To estimate the objective response rate (complete response [CR] and partial response [PR]) at trial closure.'}, {'measure': 'To estimate the disease control rate at trial closure.'}, {'measure': 'To estimate overall survival.'}, {'measure': 'To evaluate the safety & tolerability of the combination gefitinib and fulvestrant'}]}, 'conditionsModule': {'keywords': ['Advanced breast cancer', 'Metastatic breast cancer', 'ER positive breast cancer', 'PR positive breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The progression free survival and efficacy of 250 mg ZD1839 in combination with a fixed dose of fulvestrant 250 mg im once a month will be evaluated in female patients with histologically-confirmed advanced or metastatic, ER and/or PR positive breast cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed advanced or metastatic breast cancer\n* postmenopausal females with amenorrhoea \\> 12 months and an intact uterus\n* FSH levels within postmenopausal range or have undergone a bilateral oophorectomy\n* ER \\&/or PR positive\n* previous adjuvant hormone therapy \\> 12 months prior to enrolment\n* previous adjuvant chemotherapy \\> 6 months prior to enrolment\n* measurable disease according to RECIST and/or non measurable bone disease\n* life expectancy of at least 12 weeks\n* World Health Organisation (WHO) performance status (PS) of 0 to 1.\n\nExclusion Criteria:\n\n* Male\n* life-threatening metastatic visceral disease\n* evidence of clinically active interstitial lung disease\n* ER and PR negative\n* treatment with LHRH analogues \\< 3 months prior to enrolment\n* patients who have restarted menses or do not have FSH levels within the postmenopausal range\n* treatment with strontium - 90 (or other radio pharmaceutical) within the previous 3 months\n* Treatment with hormonotherapy and/or chemotherapy for advanced disease\n* extensive radiotherapy to measurable lesions within the last 4 weeks (i.e. \\>30% of bone marrow, e.g. whole of pelvis or half of spine)\n* currently receiving oestrogen replacement therapy\n* treatment with a non-approved or experimental drug within 4 weeks before enrolment\n* absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L , serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR, serum creatinine greater than 1.5 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases, history of bleeding diathesis or long term or present anticoagulant therapy (other than antiplatelet therapy\n* any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy\n* concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, known\n* severe hypersensitivity to ZD1839 or fulvestrant or any of the excipients of this product.'}, 'identificationModule': {'nctId': 'NCT00234403', 'briefTitle': 'A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '1839IL/0141'}}, 'armsInterventionsModule': {'interventions': [{'name': 'gefitinib and fulvestrant', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alicante', 'country': 'Spain', 'facility': 'Investigative Site', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Girona', 'country': 'Spain', 'facility': 'Investigative Site', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'city': 'Jaén', 'country': 'Spain', 'facility': 'Investigative Site', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Investigative Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Investigative Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Investigative Site', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'AstraZeneca Spain Medical Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}