Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 1:32 PM
Study NCT ID:
NCT00217659
Status:
WITHDRAWN
Last Update Posted:
2013-01-03
First Post:
2005-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S0511, Goserelin and Anastrozole in Treating Men With Recurrent or Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}], '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': 'D000077384', 'term': 'Anastrozole'}, {'id': 'D017273', 'term': 'Goserelin'}], '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': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'poor accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-02', 'studyFirstSubmitDate': '2005-09-20', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2013-01-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)'}, {'measure': 'Overall survival'}, {'measure': 'Overall objective tumor response rate (confirmed and unconfirmed, complete and partial)'}, {'measure': 'Correlation of prostate specific antigen, testosterone, estradiol, estrone, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone levels with PFS'}, {'measure': 'Toxicity'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['male breast cancer', 'recurrent breast cancer', 'stage IV breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using goserelin and anastrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving goserelin together with anastrozole may be an effective treatment for male breast cancer.\n\nPURPOSE: This phase II trial is studying how well giving goserelin together with anastrozole works in treating men with recurrent or metastatic breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the progression-free survival (PFS) of men with estrogen receptor- or progesterone receptor-positive recurrent or metastatic breast cancer treated with goserelin and anastrozole.\n* Determine the overall survival of patients treated with this regimen.\n* Determine the overall objective tumor response rate (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.\n* Correlate prostate specific antigen (PSA), testosterone, estradiol, estrone, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone levels with PFS and response in patients treated with this regimen.\n* Determine the toxicity of this regimen in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive goserelin subcutaneously on day 1 and oral anastrozole on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed at approximately 4-6 weeks and then every 3-6 months for up to 3 years.\n\nPROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within 48 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed breast cancer\n\n * Recurrent or metastatic (stage IV) disease\n\n * Patients with a local regional recurrence, including axillary and/or chest wall involvement, are eligible\n* Measurable or non-measurable disease\n* Brain metastases allowed provided they have been treated with surgery or radiotherapy AND have remained stable for ≥ 3 months\n* Hormone receptor status:\n\n * Estrogen receptor- OR progesterone receptor- positive disease by standard immunohistochemical techniques\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nSex\n\n* Male\n\nPerformance status\n\n* Zubrod 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* No evidence of severe or uncontrolled hepatic disease\n\nRenal\n\n* No evidence of severe or uncontrolled renal disease\n\nCardiovascular\n\n* No evidence of severe or uncontrolled cardiac disease\n\nPulmonary\n\n* No evidence of severe or uncontrolled respiratory disease\n\nOther\n\n* Fertile patients must use effective barrier-method contraception during and for 12 weeks after the completion of study treatment\n* No known HIV positivity\n* Able to receive oral medication\n\n * Patients with a gastrointestinal tube are eligible\n* No known hypersensitivity to luteinizing hormone-releasing hormone (LHRH), LHRH agonist analogues, or any components of the study drugs\n* No active infection requiring systemic therapy\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer\n* No evidence of other severe or uncontrolled systemic disease\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent prophylactic filgrastim (G-CSF) or other hematopoietic growth factors\n\nChemotherapy\n\n* At least 14 days since prior chemotherapy for this cancer and recovered\n* No more than 1 prior chemotherapy regimen for metastatic disease\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* At least 14 days since prior hormonal therapy for this cancer and recovered\n* Prior tamoxifen allowed\n* No prior gonadotropin-releasing hormone antagonist, aromatase inhibitors, or fulvestrant\n* No other concurrent hormonal therapy (e.g., estrogen-based therapies)\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 14 days since prior radiotherapy for this cancer and recovered\n* No concurrent radiotherapy\n\nSurgery\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00217659', 'briefTitle': 'S0511, Goserelin and Anastrozole in Treating Men With Recurrent or Metastatic Breast Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'A Phase II Study of Goserelin Plus Anastrozole for the Treatment of Male Patients With Hormone-Receptor Positive Metastatic or Recurrent Breast Cancer', 'orgStudyIdInfo': {'id': 'CDR0000442919'}, 'secondaryIdInfos': [{'id': 'S0511', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'anastrozole', 'type': 'DRUG'}, {'name': 'goserelin acetate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089-9181', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center and Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center at UC Health Sciences Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '81401', 'city': 'Montrose', 'state': 'Colorado', 'country': 'United States', 'facility': 'Montrose Memorial Hospital Cancer Center', 'geoPoint': {'lat': 38.47832, 'lon': -107.87617}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Exempla Lutheran Medical Center', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Broward General Medical Center Cancer Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '31403-3089', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'Decatur Memorial Hospital Cancer Care Institute', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '62781-0001', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Regional Cancer Center at Memorial Medical Center', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '66720', 'city': 'Chanute', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Chanute', 'geoPoint': {'lat': 37.67921, 'lon': -95.4572}}, {'zip': '67801', 'city': 'Dodge City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Dodge City', 'geoPoint': {'lat': 37.7528, 'lon': -100.01708}}, {'zip': '67042', 'city': 'El Dorado', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - El Dorado', 'geoPoint': {'lat': 37.81724, 'lon': -96.86225}}, {'zip': '67068', 'city': 'Kingman', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Kingman', 'geoPoint': {'lat': 37.64585, 'lon': -98.11367}}, {'zip': '67901', 'city': 'Liberal', 'state': 'Kansas', 'country': 'United States', 'facility': 'Southwest Medical Center', 'geoPoint': {'lat': 37.04308, 'lon': -100.921}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Newton', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '67357', 'city': 'Parsons', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Parsons', 'geoPoint': {'lat': 37.34034, 'lon': -95.26108}}, {'zip': '67124', 'city': 'Pratt', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Pratt', 'geoPoint': {'lat': 37.64391, 'lon': -98.73759}}, {'zip': '67042', 'city': 'Salina', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Salina', 'geoPoint': {'lat': 38.84028, 'lon': -97.61142}}, {'zip': '67401', 'city': 'Salina', 'state': 'Kansas', 'country': 'United States', 'facility': 'Tammy Walker Cancer Center at Salina Regional Health Center', 'geoPoint': {'lat': 38.84028, 'lon': -97.61142}}, {'zip': '67152', 'city': 'Wellington', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Wellington', 'geoPoint': {'lat': 37.2653, 'lon': -97.37171}}, {'zip': '67203', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Associates in Womens Health, PA - North Review', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67208', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Medical Arts Tower', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'CCOP - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Via Christi Cancer Center at Via Christi Regional Medical Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67156', 'city': 'Winfield', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Winfield', 'geoPoint': {'lat': 37.23975, 'lon': -96.99559}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Josephine Ford Cancer Center at Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '65802', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'CCOP - Cancer Research for the Ozarks', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': "St. John's Regional Health Center", 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'CCOP - Montana Cancer Consortium', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Hematology-Oncology Centers of the Northern Rockies - Billings', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Northern Rockies Radiation Oncology Center', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'St. Vincent Healthcare', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '59107-5100', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Billings Clinic Cancer Center', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '59107-7000', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Deaconess Billings Clinic - Downtown', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '59715', 'city': 'Bozeman', 'state': 'Montana', 'country': 'United States', 'facility': 'Bozeman Deaconess Hospital', 'geoPoint': {'lat': 45.67965, 'lon': -111.03856}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'facility': 'St. James Community Hospital', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '59405', 'city': 'Great Falls', 'state': 'Montana', 'country': 'United States', 'facility': 'Great Falls Clinic', 'geoPoint': {'lat': 47.50024, 'lon': -111.30081}}, {'zip': '59405', 'city': 'Great Falls', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 47.50024, 'lon': -111.30081}}, {'zip': '59601', 'city': 'Helena', 'state': 'Montana', 'country': 'United States', 'facility': "St. Peter's Hospital", 'geoPoint': {'lat': 46.59271, 'lon': -112.03611}}, {'zip': '59901', 'city': 'Kalispell', 'state': 'Montana', 'country': 'United States', 'facility': 'Glacier Oncology, PLLC', 'geoPoint': {'lat': 48.19579, 'lon': -114.31291}}, {'zip': '59901', 'city': 'Kalispell', 'state': 'Montana', 'country': 'United States', 'facility': 'Kalispell Medical Oncology', 'geoPoint': {'lat': 48.19579, 'lon': -114.31291}}, {'zip': '59901', 'city': 'Kalispell', 'state': 'Montana', 'country': 'United States', 'facility': 'Kalispell Regional Medical Center', 'geoPoint': {'lat': 48.19579, 'lon': -114.31291}}, {'zip': '59801', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Community Medical Center', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '59804', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Guardian Oncology and Center for Wellness', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '59807-7877', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Montana Cancer Specialists at Montana Cancer Center', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '59807', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Montana Cancer Center at St. Patrick Hospital and Health Sciences Center', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '27534', 'city': 'Goldsboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wayne Memorial Hospital, Incorporated', 'geoPoint': {'lat': 35.38488, 'lon': -77.99277}}, {'zip': '28139', 'city': 'Rutherfordton', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Rutherford Hospital', 'geoPoint': {'lat': 35.36929, 'lon': -81.95677}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44131', 'city': 'Independence', 'state': 'Ohio', 'country': 'United States', 'facility': 'Community Oncology Group at Cleveland Clinic Cancer Center', 'geoPoint': {'lat': 41.36866, 'lon': -81.6379}}, {'zip': '44691', 'city': 'Wooster', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic - Wooster', 'geoPoint': {'lat': 40.80517, 'lon': -81.93646}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'AnMed Health Cancer Center', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'CCOP - Upstate Carolina', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Gibbs Regional Cancer Center at Spartanburg Regional Medical Center', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '82801', 'city': 'Sheridan', 'state': 'Wyoming', 'country': 'United States', 'facility': 'Welch Cancer Center at Sheridan Memorial Hospital', 'geoPoint': {'lat': 44.79719, 'lon': -106.95618}}], 'overallOfficials': [{'name': 'Zeina Nahleh, MD', 'affiliation': 'Barrett Cancer Center'}, {'name': 'Abdul-Rahman Jazieh, MD, MPH', 'affiliation': 'Barrett Cancer Center'}, {'name': 'Robert B. Livingston, MD', 'affiliation': 'University of Washington'}, {'name': 'Gabriel N. Hortobagyi, MD, FACP', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}