Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-02 @ 12:52 PM
Study NCT ID:
NCT00244959
Status:
COMPLETED
Last Update Posted:
2013-03-19
First Post:
2005-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anastrozole in Treating Postmenopausal Women With DCIS or Stage I-III Breast Cancer
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': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], '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': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-18', 'studyFirstSubmitDate': '2005-10-25', 'studyFirstSubmitQcDate': '2005-10-25', 'lastUpdatePostDateStruct': {'date': '2013-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in breast density after 12 months of treatment', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Change in hormone levels after 12 months of treatment', 'timeFrame': '12 months'}, {'measure': 'Comparison between change in breast density with change in hormone levels after 12 months of treatment', 'timeFrame': '12 months'}, {'measure': 'Comparison between the frequency of aromatase polymorphisms with changes in breast density and hormone levels after 12 months of treatment', 'timeFrame': '12 months'}, {'measure': 'Comparison between change in bone density with change in hormone levels after 12 months of treatment', 'timeFrame': '12 months'}, {'measure': 'Comparison between tissue methylation with changes in breast density and hormone levels after 12 months of treatment', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer', 'ductal breast carcinoma in situ', 'breast cancer in situ'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '21885816', 'type': 'RESULT', 'citation': 'Prowell TM, Blackford AL, Byrne C, Khouri NF, Dowsett M, Folkerd E, Tarpinian KS, Powers PP, Wright LA, Donehower MG, Jeter SC, Armstrong DK, Emens LA, Fetting JH, Wolff AC, Garrett-Mayer E, Skaar TC, Davidson NE, Stearns V. Changes in breast density and circulating estrogens in postmenopausal women receiving adjuvant anastrozole. Cancer Prev Res (Phila). 2011 Dec;4(12):1993-2001. doi: 10.1158/1940-6207.CAPR-11-0154. Epub 2011 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes.\n\nPURPOSE: This phase II trial is studying how anastrozole effects postmenopausal women who have undergone surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the 12-month change in breast density in postmenopausal women with ductal carcinoma in situ (DCIS) or stage I-III breast cancer treated with adjuvant anastrozole.\n\nSecondary\n\n* Determine the change in estrone sulfate levels in patients treated with this drug.\n* Correlate the change in breast density with the change in circulating estrone sulfate levels in patients treated with this drug.\n* Determine the frequency of polymorphisms in aromatase (CYP19) and evaluate the relationship between wild-type aromatase enzyme with change in breast density and change in estrone sulfate levels in patients treated with this drug.\n* Determine the 12-month change in bone density, and correlate it with the change in circulating estrone sulfate levels in patients treated with this drug.\n* Correlate the reversal of hypermethylation with change in circulating estrone sulfate levels and breast density in patients treated with this drug.\n\nOUTLINE: This is a pilot study. Patients are stratified according to concurrent bisphosphonate use (yes vs no).\n\nPatients receive oral anastrozole once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.\n\nPROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed breast cancer meeting 1 of the following criteria:\n\n * Ductal carcinoma in situ (DCIS)\n * Invasive carcinoma\n\n * Stage I-III disease\n* Must have undergone breast cancer surgery within the past 6 months, including any of the following:\n\n * Mastectomy or lumpectomy with or without radiation\n * Sentinel node and/or axillary node dissection\n * Re-excision of lumpectomy margins\n* Intact contralateral breast\n\n * No prior radiation therapy or mastectomy\n * Prior biopsies allowed\n* Hormone receptor status:\n\n * Estrogen and/or progesterone receptor-positive tumor by immunohistochemical staining\n\nPATIENT CHARACTERISTICS:\n\nSex\n\n* Female\n\nMenopausal status\n\n* Postmenopausal, defined as 1 of the following:\n\n * At least 60 years of age\n * Less than 60 years of age and amenorrheic ≥ 12 months prior to study entry\n * Less than 60 years of age, amenorrheic for \\< 12 months prior to day 1, and luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range\n * Less than 60 years of age, without a uterus, and LH and FSH values within postmenopausal range\n * Underwent prior bilateral oophorectomy\n * Underwent prior radiation castration AND amenorrheic for ≥ 6 months\n\nPerformance status\n\n* ECOG 0-2\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\nPRIOR CONCURRENT THERAPY:\n\nChemotherapy\n\n* No prior or concurrent adjuvant chemotherapy for breast cancer\n\nEndocrine therapy\n\n* No prior aromatase inhibitor\n* At least 6 weeks since prior and no concurrent tamoxifen\n* At least 6 weeks since prior and no concurrent hormone replacement therapy\n\n * Concurrent low-dose, local vaginal estrogen in the form of either a conjugated estrogen ring or other similar product (e.g., Estring® or Vagifem®) allowed\n* At least 6 weeks since prior and no other concurrent selective estrogen receptor modulators (e.g., raloxifene)\n\nRadiotherapy\n\n* See Disease Characteristics\n\nSurgery\n\n* See Disease Characteristics\n* No contralateral breast implant\n\nOther\n\n* Concurrent bisphosphonates allowed at the discretion of the treating oncologist\n* No concurrent consumption of soy supplements\n\n * Concurrent routine dietary consumption of soy-containing foods allowed\n* No other concurrent investigational or commercial drugs or therapies for the treatment of DCIS or invasive breast cancer'}, 'identificationModule': {'nctId': 'NCT00244959', 'briefTitle': 'Anastrozole in Treating Postmenopausal Women With DCIS or Stage I-III Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy', 'orgStudyIdInfo': {'id': 'J0365 CDR0000446285'}, 'secondaryIdInfos': [{'id': 'P30CA006973', 'link': 'https://reporter.nih.gov/quickSearch/P30CA006973', 'type': 'NIH'}, {'id': 'JHOC-J0365', 'type': 'OTHER', 'domain': 'SKCCC at Johns Hopkins'}, {'id': 'JHOC-SKCCC-J0365', 'type': 'OTHER', 'domain': 'SKCCC at Johns Hopkins'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anastrozole', 'description': 'Anastrozole (1mg, orally, daily) for 12 months as adjuvant therapy for breast cancer', 'interventionNames': ['Drug: anastrozole', 'Procedure: adjuvant therapy']}], 'interventions': [{'name': 'anastrozole', 'type': 'DRUG', 'otherNames': ['Arimidex'], 'description': '1 mg orally daily for 12 months', 'armGroupLabels': ['Anastrozole']}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE', 'description': 'treatment received after breast cancer surgery', 'armGroupLabels': ['Anastrozole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231-2410', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Vered Stearns, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}