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Anastrozole With or Without Fulvestrant as First-Line Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Anastrozole With or Without Fulvestrant as First-Line Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Anastrozole With or Without Fulvestrant as First-Line Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer Clinical research trials and Anastrozole With or Without Fulvestrant as First-Line Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Anastrozole With or Without Fulvestrant as First-Line Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer. Anastrozole With or Without Fulvestrant as First-Line Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Anastrozole With or Without Fulvestrant as First-Line Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer clinical trial. Human subjects often get the best healthcare available for their Anastrozole With or Without Fulvestrant as First-Line Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.

Home > "A" Clinical Trials Conditions > Anastrozole With or Without Fulvestrant as First-Line Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer

Anastrozole With or Without Fulvestrant as First-Line Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer



Anastrozole With or Without Fulvestrant as First-Line Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer

For Condition: stage 4 breast cancer,recurrent breast cancer
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the uptake of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of anastrozole with or without fulvestrant as first-line therapy in treating postmenopausal women who have metastatic breast cancer.
Details: OBJECTIVES: - Compare the time to tumor progression in postmenopausal women with metastatic breast cancer treated with anastrozole with or without fulvestrant as first-line therapy. - Compare the clinical benefit (complete or partial response, confirmed or unconfirmed, or stable disease ≥ 24 weeks) and overall survival of patients treated with these regimens. - Compare adverse events in patients treated with these regimens. - Determine the prognostic significance of estrogen receptor positivity and HER2/neu status in patients treated with these regimens. - Determine parameters of estrogen and clinical pharmacology and estrogen levels in patients treated with these regimens. - Compare anastrozole plasma levels at 8, 16, and 24 weeks in patients treated with these regimens. - Compare estradiol serum levels at 8, 16, and 24 weeks in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant tamoxifen therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral anastrozole once daily on days 1-28. - Arm II: Patients receive oral anastrozole as in arm I and fulvestrant intramuscularly on day 1. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually for 3 years. PROJECTED ACCRUAL: A total of 690 patients (345 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer meeting 1 of the following criteria: - Metastatic disease (M1) - Multiple sites of new disease that is clinically obvious metastatic disease (e.g., multiple sites of new osseous disease) - Measurable or nonmeasurable disease - No known brain or CNS metastases - Hormone receptor status: - Estrogen-receptor positive* AND/OR - Progesterone-receptor positive* NOTE: *Positivity defined as estrogen binding of > 10 fmol/mg cytosol protein by ligand binding assay or positive by immunohistochemistry PATIENT CHARACTERISTICS: Age - Not specified Sex - Female Menopausal status - Postmenopausal, as defined by 1 of the following: - Prior bilateral oophorectomy - More than 12 months since last menstrual period with no prior hysterectomy - At least 55 years of age with prior hysterectomy - Under 55 years of age with a prior hysterectomy without oophorectomy and with estradiol and follicle-stimulating hormone levels consistent with menopause Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - No bleeding diathesis (e.g., disseminated intravascular coagulation or clotting factor deficiency) Hepatic - INR 1.6 Renal - Not specified Other - HIV negative - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy - No prior immunotherapy for recurrent or metastatic disease - No concurrent immunotherapy for malignancy Chemotherapy - No prior chemotherapy for recurrent or metastatic disease - More than 12 months since prior adjuvant or neoadjuvant chemotherapy - No concurrent chemotherapy for malignancy Endocrine therapy - No prior hormonal therapy for recurrent or metastatic disease - Prior adjuvant hormonal therapy allowed - No prior adjuvant or neoadjuvant (e.g., anastrozole, letrozole, or exemestane) aromatase inhibitors - No prior fulvestrant - At least 12 months since prior adjuvant luteinizing hormone-releasing hormone (LHRH) analogues - Menstrual periods must not have resumed since LHRH therapy - No other concurrent hormonal therapy for malignancy - No concurrent hormone replacement therapy Radiotherapy - Not specified Surgery - Not specified Other - No long-term anticoagulant therapy (except antiplatelet therapy)
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RitaMehta,  ,  Chao Family Comprehensive Cancer Center

MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque,  New Mexico,  87131
United States
Recruiting Cheryl  Willman 505-272-5837

Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood,  Illinois,  60153-5500
United States
Recruiting Patrick  Stiff 708-327-3148

CCOP - Dayton *Recruiting*
Dayton,  Ohio,  45429
United States
Recruiting Howard  Gross 937-395-8678

MBCCOP - Gulf Coast *Recruiting*
Mobile,  Alabama,  36607
United States
Recruiting Paul  Schwarzenberger 251-544-1013

Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati,  Ohio,  45267-0501
United States
Recruiting Abdul-Rahman  Jazieh 513-584-3830

CCOP - Grand Rapids *Recruiting*
Grand Rapids,  Michigan,  49503
United States
Recruiting Kathleen  Yost 616-391-1230

Veterans Affairs Medical Center - Little Rock (McClellan) *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Bart  Barlogie 501-526-2873

Veterans Affairs Medical Center - Denver *Recruiting*
Denver,  Colorado,  80220
United States
Recruiting Madeleine  Kane 303-399-8020 ext. 3129

Tulane University School of Medicine *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Alan  Miller 504-587-7566

James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester,  New York,  14642
United States
Recruiting Richard  Fisher 585-275-0842

Southwest Cancer Center at UMC *Recruiting*
Lubbock,  Texas,  79415-3364
United States
Recruiting Werner  W. DeRiese 806-775-8590

Veterans Affairs Medical Center - Oklahoma City *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Howard  Ozer 405-270-0501

CCOP - St. Louis-Cape Girardeau *Recruiting*
St. Louis,  Missouri,  63141
United States
Recruiting Patrick  Henry 314-569-6573

Veterans Affairs Medical Center - Charleston *Recruiting*
Charleston,  South Carolina,  29401-5799
United States
Recruiting Carolyn  Reed 843-789-7865

Veterans Affairs Medical Center - Amarillo *Recruiting*
Amarillo,  Texas,  79106
United States
Recruiting William  Robinson 806-355-9703

Veterans Affairs Medical Center - Salt Lake City *Recruiting*
Salt Lake City,  Utah,  84148
United States
Recruiting Wolfram  Samlowski 801-582-1565

USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles,  California,  90033
United States
Recruiting Heinz-Josef  Lenz 323-865-3955

Tripler Army Medical Center *Recruiting*
Honolulu,  Hawaii,  96859-5000
United States
Recruiting Brian  Issell 808-433-4089

University of Tennessee Cancer Institute *Recruiting*
Memphis,  Tennessee,  38103
United States
Recruiting Mohammad  Jahanzeb 901-722-0532

Veterans Affairs Medical Center - Memphis *Recruiting*
Memphis,  Tennessee,  38104
United States
Recruiting Mohammad  Jahanzeb 901-523-8990

Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit,  Michigan,  48202
United States
Recruiting Robert  Chapman 313-916-1850

CCOP - Santa Rosa Memorial Hospital *Recruiting*
Santa Rosa,  California,  95403
United States
Recruiting Ian  Anderson 707-521-3859

CCOP - Wichita *Recruiting*
Wichita,  Kansas,  67214-3882
United States
Recruiting Shaker  Dakhil 316-268-5784

Veterans Affairs Medical Center - San Antonio (Murphy) *Recruiting*
San Antonio,  Texas,  78229
United States
Recruiting Geoffrey  Weiss 210-617-5120

University of Mississippi Medical Center *Recruiting*
Jackson,  Mississippi,  39216-4505
United States
Recruiting James  Thigpen 601-984-5590

Veterans Affairs Medical Center - Detroit *Recruiting*
Detroit,  Michigan,  48201-1932
United States
Recruiting Lawrence  Flaherty 313-576-1000

Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tucson,  Arizona,  85724
United States
Recruiting Thomas  Miller 520-626-2667

City of Hope Comprehensive Cancer Center *Recruiting*
Duarte,  California,  91010-0269
United States
Recruiting Kim  Margolin 626-359-8111

Veterans Affairs Medical Center - Tucson *Recruiting*
Tucson,  Arizona,  85723
United States
Recruiting Thomas  Miller 520-792-1450 ext. 16631

Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport,  Louisiana,  71130-3932
United States
Recruiting Glenn  Mills 318-675-7639

Eastern Virginia Medical School *Recruiting*
Norfolk,  Virginia,  23510-1115
United States
Recruiting Paul  Schellhammer 804-628-2409

CCOP - Atlanta Regional *Recruiting*
Atlanta,  Georgia,  30342-1701
United States
Recruiting Thomas  Seay 404-851-2340

University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora,  Colorado,  80010
United States
Recruiting Anthony  Elias 720-848-1622

Brooke Army Medical Center *Recruiting*
Fort Sam Houston,  Texas,  78234-6200
United States
Recruiting Mitchell  Garrison 210-916-0504

Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City,  Kansas,  66160-7353
United States
Recruiting Sarah  Taylor 913-588-6029

Veterans Affairs Medical Center - Dayton *Recruiting*
Dayton,  Ohio,  45428-1002
United States
Recruiting Howard  Gross 937-268-6511

Veterans Affairs Medical Center - Kansas City *Recruiting*
Kansas City,  Missouri,  64128
United States
Recruiting Sarah  Taylor 816-861-4700 ext. 491

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange,  California,  92868
United States
Recruiting Randall  Holcombe 714-456-5153

Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland,  Ohio,  44195-9001
United States
Recruiting George  Budd 216-444-6480

Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita,  Kansas,  67218
United States
Recruiting Shaker  Dakhil 316-685-2221

Madigan Army Medical Center *Recruiting*
Tacoma,  Washington,  98431-5000
United States
Recruiting Patrick  Williams 253-968-2505

University of Arkansas for Medical Sciences *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Laura  Hutchins 501-686-8511

Veterans Affairs Outpatient Clinic - Martinez *Recruiting*
Martinez,  California,  94553
United States
Recruiting David  Gandara 925-372-2064

David Grant Medical Center *Recruiting*
Travis Air Force Base,  California,  94535
United States
Recruiting David  Gandara 707-423-7300

Veterans Affairs Medical Center - Lexington *Recruiting*
Lexington,  Kentucky,  40502-2236
United States
Recruiting Michael  Doukas 859-281-4956

Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City,  New York,  10032
United States
Recruiting Daniel  Petrylak 212-305-1731

Veterans Affairs Medical Center - Cincinnati *Recruiting*
Cincinnati,  Ohio,  45220-2288
United States
Recruiting Abdul-Rahman  Jazieh 513-861-3100 ext. 6537

Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus,  Ohio,  43210-1240
United States
Recruiting David  Schuller 614-293-4878

Harrington Cancer Center *Recruiting*
Amarillo,  Texas,  79106
United States
Recruiting James  Clarkson 806-359-4673

CCOP - Columbia River Oncology Program *Recruiting*
Portland,  Oregon,  97225
United States
Recruiting Keith  Lanier 503-216-6260

Cancer Research Center of Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Brian  Issell 808-586-3013

MBCCOP - Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Brian  Issell 808-586-3013

Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Thomas  Lad 312-996-2046

MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Jill  Gilbert 504-568-5136

Western New York Urology Associates *Recruiting*
Buffalo,  New York,  14220
United States
Recruiting Scott  Perrapato 716-828-3369

CCOP - Columbus *Recruiting*
Columbus,  Ohio,  43206
United States
Recruiting J.  Kuebler 614-488-2118

Cancer Institute at Oregon Health and Science University *Recruiting*
Portland,  Oregon,  97201-3098
United States
Recruiting Craig  Nichols 503-494-6346

CCOP - Upstate Carolina *Recruiting*
Spartanburg,  South Carolina,  29303
United States
Recruiting James  Bearden 864-560-7050

CCOP - Northwest *Recruiting*
Tacoma,  Washington,  98405-0986
United States
Recruiting Lauren  Colman 253-403-1461

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) *Recruiting*
Hines,  Illinois,  60141
United States
Recruiting Nirmala  Bhoopalam 708-202-2782

Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston,  South Carolina,  29425
United States
Recruiting Carolyn  Reed 843-792-3362

St. Louis University Hospital Cancer Center *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Paul  Petruska 314-577-8854

CCOP - Beaumont *Recruiting*
Royal Oak,  Michigan,  48073-6769
United States
Recruiting David  Decker 248-551-7695

CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor,  Michigan,  48106
United States
Recruiting Philip  Stella 734-712-2000

Veterans Affairs Medical Center - Jackson *Recruiting*
Jackson,  Mississippi,  39216
United States
Recruiting James  Thigpen 601-362-4471

Baylor College of Medicine *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Seth  Lerner 713-798-5906

Veterans Affairs Medical Center - Temple *Recruiting*
Temple,  Texas,  76504
United States
Recruiting Phalguni  Mukhopadhyay 254-778-4811 ext. 4809

Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington,  Kentucky,  40536-0084
United States
Recruiting Michael  Doukas 859-257-4500

Cancer Research Center at Boston Medical Center *Recruiting*
Boston,  Massachusetts,  02118
United States
Recruiting Douglas  Faller 617-638-8000

Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit,  Michigan,  48201-1379
United States
Recruiting Lawrence  Flaherty 313-745-9155

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4095
United States
Recruiting Scott  Lippman 713-745-3672

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) *Recruiting*
Phoenix,  Arizona,  85012
United States
Recruiting Thomas  Kummet 602-277-5551

Veterans Affairs Medical Center - Boston (Jamaica Plain) *Recruiting*
Jamaica Plain,  Massachusetts,  02130
United States
Recruiting Michelle  Hankins 617-232-9500

Veterans Affairs Medical Center - Shreveport *Recruiting*
Shreveport,  Louisiana,  71130
United States
Recruiting Glenn  Mills 318-221-8411

CCOP - Greenville *Recruiting*
Greenville,  South Carolina,  29615
United States
Recruiting Jeffrey  Giguere 864-241-6251

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus *Recruiting*
Seattle,  Washington,  98104
United States
Recruiting Saul  Rivkin 206-386-2929

Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago,  Illinois,  60611
United States
Recruiting David  Fishman 312-926-7365

MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C.,  District of Columbia,  20060
United States
Recruiting Lucile  Adams-Campbell 202-806-7697

MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Lawrence  Feldman 312-335-3614

Veterans Affairs Medical Center - Albany *Recruiting*
Albany,  New York,  12208
United States
Recruiting James  Holland 518-462-3311 ext. 2328

University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio,  Texas,  78229-3900
United States
Recruiting Geoffrey  Weiss 210-617-5120

Veterans Affairs Medical Center - Ann Arbor *Recruiting*
Ann Arbor,  Michigan,  48105
United States
Recruiting Laurence  Baker 734-769-7100

Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi,  Mississippi,  39531-2410
United States
Recruiting Robert  Veith 504-568-5151

Veterans Affairs Medical Center - Seattle *Recruiting*
Seattle,  Washington,  98108
United States
Recruiting William  Schubach 206-764-2265

Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles,  California,  90095-1781
United States
Recruiting John  Barstis 310-825-5268

Veterans Affairs Medical Center - Albuquerque *Recruiting*
Albuquerque,  New Mexico,  87108-5138
United States
Recruiting Douglas  Clark 505-243-4039

Huntsman Cancer Institute *Recruiting*
Salt Lake City,  Utah,  84112-5550
United States
Recruiting Wolfram  Samlowski 801-585-0255

Veterans Affairs Medical Center - New Orleans *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Alan  Miller 504-589-5250

CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem,  North Carolina,  27104-4241
United States
Recruiting James  Atkins 336-777-3036

CCOP - Western Regional, Arizona *Recruiting*
Phoenix,  Arizona,  85006-2726
United States
Recruiting David  King 602-258-4875

Veterans Affairs Medical Center - San Francisco *Recruiting*
San Francisco,  California,  94121
United States
Recruiting Peter  Carroll 415-221-4810

CCOP - Montana Cancer Consortium *Recruiting*
Billings,  Montana,  59101
United States
Recruiting Patrick  Cobb 406-259-2245

University of Texas Medical Branch *Recruiting*
Galveston,  Texas,  77555-0565
United States
Recruiting Robert  Whitehead 409-772-1164

Mayo Clinic *Recruiting*
Jacksonville,  Florida,  32224
United States
Recruiting Edith  Perez 904-953-0118

University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor,  Michigan,  48109-0912
United States
Recruiting Laurence  Baker 734-936-3983

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

CCOP - Bay Area Tumor Institute *Recruiting*
Oakland,  California,  94609-3305
United States
Recruiting Joseph  Szumowski 510-465-8570

Providence Cancer Institute at Providence Hospital *Recruiting*
Southfield,  Michigan,  48075
United States
Recruiting Anibal  Drelichman 313-552-0620

Veterans Affairs Medical Center - Portland *Recruiting*
Portland,  Oregon,  97207
United States
Recruiting Craig  Nichols 503-220-8262

CCOP - Central Illinois *Recruiting*
Decatur,  Illinois,  62526
United States
Recruiting James  Wade 217-876-6617

CCOP - Virginia Mason Research Center *Recruiting*
Seattle,  Washington,  98101
United States
Recruiting Andrew  Jacobs 206-341-0446

CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield,  Missouri,  65807
United States
Recruiting John  Goodwin 417-269-4520

CCOP - Scott and White Hospital *Recruiting*
Temple,  Texas,  76508
United States
Recruiting Lucas  Wong 254-724-7048

Veterans Affairs Medical Center - Houston *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Gauri  Varadhachary 713-791-1414 ext. 5340

Fletcher Allen Health Care - University Health Center Campus *Recruiting*
Burlington,  Vermont,  05401
United States
Recruiting Steven  Grunberg 802-847-8400

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Howard  Ozer 405-271-4022

MBCCOP - Massey Cancer Center *Recruiting*
Richmond,  Virginia,  23298-0037
United States
Recruiting John  Roberts 804-828-0450


Additional Information:
Study ID Numbers:
  CDR0000349337;  SWOG-S0226
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075764

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