Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-01-02 @ 12:03 PM
Study NCT ID:
NCT00082667
Status:
TERMINATED
Last Update Posted:
2013-02-25
First Post:
2004-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], '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': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077156', 'term': 'Gefitinib'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015412', 'term': 'Mastectomy, Segmental'}], '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': 'D008408', 'term': 'Mastectomy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'PI left VICC', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-22', 'studyFirstSubmitDate': '2004-05-14', 'studyFirstSubmitQcDate': '2004-05-18', 'lastUpdatePostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlate levels of HER2 extracellular domain in ER-positive vs. ER-negative and in HER2-positive cs. HER2-negative patients', 'timeFrame': 'at time of surgery, after 7-14 days of gefitinib'}], 'primaryOutcomes': [{'measure': 'Compare epidermal growth factor receptor (EGFR) pathway biomarker modulation in tissue samples of women with ductal carcinoma in situ (DCIS) of the breast treated with gefitinib vs placebo followed by surgery.', 'timeFrame': 'at time of surgery, after 7-14 days of gefitinib'}], 'secondaryOutcomes': [{'measure': 'Compare the effect of gefitinib vs. placebo, followed by surgery on cell turnover in vivo in EGFR-positive vs. EGFR-negative patients', 'timeFrame': 'at time of surgery, after 7-14 days of gefitinib'}, {'measure': 'Compare the effects of gefitinib in ER-positive vs. ER-negative DCIS and in HER2-positive vs. HER2-negative DCIS', 'timeFrame': 'at time of surgery, after 7-14 days of gefitinib'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast cancer in situ', 'ductal breast carcinoma in situ'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether surgery is more effective with or without gefitinib in treating ductal carcinoma in situ.\n\nPURPOSE: This randomized phase II trial is studying how well gefitinib together with surgery works compared to surgery alone for the treatment of women with ductal carcinoma in situ of the breast.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare epidermal growth factor receptor (EGFR) pathway biomarker modulation in tissue samples of women with ductal carcinoma in situ (DCIS) of the breast treated with gefitinib vs placebo followed by local surgery.\n* Compare the effect of these regimens on cell turnover in vivo in EGFR-positive vs EGFR-negative patients.\n\nSecondary\n\n* Compare the efficacy of these regimens in estrogen-receptor (ER)-positive vs ER-negative and in HER2-positive vs HER2-negative patients with DCIS.\n* Correlate levels of HER2 extracellular domain with biomarker modulation in patients treated with these regimens.\n\nOUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral gefitinib once daily for 7-14 days or until the day before local surgery. Patients then undergo lumpectomy or mastectomy.\n* Arm II: Patients receive oral placebo once daily for 7-14 days or until the day before local surgery. Patients then undergo local surgery as in arm I.\n\nPROJECTED ACCRUAL: A total of 78 patients (39 per treatment arm) will be accrued for this study within 1.5 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR mammogram highly suspicious for DCIS\n\n * No invasive disease\n * Not completely excised\n* Epidermal growth factor receptor (EGFR) positive (\\> 10% of cells stained)\n* Planned lumpectomy or mastectomy within the next 2-4 weeks\n* Hormone receptor status:\n\n * Estrogen receptor status known\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 35 and over\n\nSex\n\n* Female\n\nMenopausal status\n\n* Not specified\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Granulocyte count \\> 1,500/mm\\^3\n* Platelet count \\> 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin \\< 1.5 mg/dL\n* SGOT ≤ 2 times upper limit of normal (ULN)\n* SGPT \\< 1.5 times ULN\n* PT and PTT ≤ 1.5 times ULN\n* INR ≤ 1.5 times ULN\n\nRenal\n\n* Creatinine \\< 1.5 mg/dL\n\nCardiovascular\n\n* No New York Heart Association class I-IV heart disease\n\nPulmonary\n\n* No acute asthma\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Random blood sugar \\< 2.5 times ULN\n* No known hypersensitivity to study drug or its excipients\n* No nonhealing wound or fracture\n* No active infection\n* No other malignancy within the past 5 years except basal cell carcinoma, breast carcinoma, or carcinoma in situ of the cervix\n* No psychosis or severe depression\n* No other concurrent uncontrolled illness\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior trastuzumab (Herceptin®)\n\nChemotherapy\n\n* At least 1 year since prior chemotherapy\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* At least 1 year since prior aromatase inhibitors\n* At least 1 year since prior antiestrogens or luteinizing hormone-releasing hormone agonists or antagonists\n* No concurrent glucocorticoids\n* Concurrent oral contraceptives allowed\n* Concurrent hormone replacement therapy allowed\n\nRadiotherapy\n\n* At least 1 year since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery\n\n* See Disease Characteristics\n* Recovered from prior oncologic or other major surgery\n* No prior organ allograft\n\nOther\n\n* Recovered from all prior therapy (except alopecia)\n* More than 30 days since prior non-approved or investigational drugs\n* No prior definitive local therapy\n* No prior immunosuppressive therapy\n* No prior gefitinib\n* No other prior EGFR inhibitors\n* No other concurrent cytotoxic drugs\n* No concurrent warfarin for anticoagulation\n* No concurrent CYP3A4 inducers, including any of the following:\n\n * Phenytoin\n * Carbamazepine\n * Barbiturates\n * Rifampin\n * Phenobarbital\n * Hypericum perforatum (St. John's wort)\n * Ethosuximide\n * Griseofulvin\n * Nafcillin\n * Nelfinavir\n * Nevirapine\n * Oxcarbazepine\n * Phenylbutazone\n * Primidone\n * Rifabutin\n * Rofecoxib\n * Sulfamethazine\n * Sulfinpyrazone\n * Troglitazone\n* No concurrent antiretroviral treatment for HIV-positive patients"}, 'identificationModule': {'nctId': 'NCT00082667', 'briefTitle': 'Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'EGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast', 'orgStudyIdInfo': {'id': 'VICC BRE 0249'}, 'secondaryIdInfos': [{'id': 'P30CA068485', 'link': 'https://reporter.nih.gov/quickSearch/P30CA068485', 'type': 'NIH'}, {'id': 'VICC-BRE-0249'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gefitinib', 'type': 'DRUG', 'otherNames': ['ZD 1839, Iressa']}, {'name': 'Surgery', 'type': 'PROCEDURE', 'otherNames': ['lumpectomy or mastectomy of the breast']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37208', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Meharry Medical College', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232-6838', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Mayer Mayer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist', 'investigatorFullName': 'Ingrid Mayer, MD', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}