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Anastrozole and Gefitinib Compared With Fulvestrant and Gefitinib in Treating Postmenopausal Women With Recurrent or Metastatic Breast Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Anastrozole and Gefitinib Compared With Fulvestrant and Gefitinib in Treating Postmenopausal Women With Recurrent or Metastatic Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Anastrozole and Gefitinib Compared With Fulvestrant and Gefitinib in Treating Postmenopausal Women With Recurrent or Metastatic Breast Cancer Clinical research trials and Anastrozole and Gefitinib Compared With Fulvestrant and Gefitinib in Treating Postmenopausal Women With Recurrent or Metastatic Breast Cancer medical trials happen in hundreds of localities throughout the U.S.A.. 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 does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Anastrozole and Gefitinib Compared With Fulvestrant and Gefitinib in Treating Postmenopausal Women With Recurrent or Metastatic Breast Cancer. Anastrozole and Gefitinib Compared With Fulvestrant and Gefitinib in Treating Postmenopausal Women With Recurrent or Metastatic Breast Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Anastrozole and Gefitinib Compared With Fulvestrant and Gefitinib in Treating Postmenopausal Women With Recurrent or Metastatic Breast Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Anastrozole and Gefitinib Compared With Fulvestrant and Gefitinib in Treating Postmenopausal Women With Recurrent or Metastatic Breast Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Anastrozole and Gefitinib Compared With Fulvestrant and Gefitinib in Treating Postmenopausal Women With Recurrent or Metastatic Breast Cancer  Anastrozole and Gefitinib Compared With Fulvestrant and Gefitinib in Treating Postmenopausal Women With Recurrent or Metastatic Breast Cancer
Anastrozole and Gefitinib Compared With Fulvestrant and Gefitinib in Treating Postmenopausal Women With Recurrent or Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole and fulvestrant may fight breast cancer by blocking the uptake of estrogen. Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. It is not yet known whether gefitinib is more effective when combined with anastrozole or fulvestrant in treating breast cancer. PURPOSE: Randomizedphase II trial to study the effectiveness of anastrozole and gefitinib compared with fulvestrant and gefitinib in treating postmenopausal women who have recurrent or metastatic breast cancer.
Details: OBJECTIVES: - Compare the antitumor activity of anastrozole and gefitinib vs fulvestrant and gefitinib in postmenopausal women with recurrent or metastatic hormone receptor-positive breast cancer. - Compare the safety of these regimens in these patients. - Compare the interaction of biological predictors of response in patients treated with these regimens. OUTLINE: This is a randomized, open-label study. Patients are stratified according to prior hormonal therapy (yes vs no) and dominant site of disease (soft tissue/lymph nodes vs bone vs visceral). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral anastrozole and oral gefitinib once daily on days 1-28. - Arm II: Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28. Courses in both arms repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 148 patients (74 per treatment arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the breast - Recurrent or metastatic disease - Measurable disease - Patients with available tissue blocks from either the primary or metastatic site must submit the tissue for epidermal growth factor receptor analysis - No history of CNS metastasis - Hormone receptor status: - Estrogen and/or progesterone receptor positive PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Postmenopausal* defined by 1 of the following: - Prior bilateral oophorectomy or bilateral ovarian irradiation - No menstrual period for at least 12 months NOTE: *If age 55 and under and on tamoxifen within the past 6 months, must have an estradiol level in the postmenopausal range Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases are present) - INR, PT, and PTT normal Renal - Creatinine clearance at least 30 mL/min Other - Not pregnant or nursing - No untreated ocular inflammation or infection - No medical or psychiatric condition that would preclude study compliance, ability to give informed consent, or assessment of response or anticipated toxic effects - No prior invasive malignancies within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No contraindication to intramuscular injections PRIOR CONCURRENT THERAPY: Biologic therapy - More than 3 weeks since prior trastuzumab (Herceptin) - No concurrent trastuzumab Chemotherapy - More than 3 weeks since prior chemotherapy - No more than 2 prior chemotherapy regimens for metastatic disease - No concurrent chemotherapy Endocrine therapy - More than 3 months since prior luteinizing hormone-releasing hormone agonists or antagonists (patients 55 years old and under) - No prior hormonal therapy for metastatic disease - No prior estrogen receptor down-regulators (e.g., fulvestrant) - No prior aromatase inhibitors (e.g., anastrozole, letrozole, exemestane, or aminoglutethimide) - No other concurrent hormonal therapy Radiotherapy - Recovered from prior radiotherapy - Concurrent radiotherapy to painful sites of bony disease or areas of impending fracture is allowed provided the following conditions are met: - Therapy was initiated prior to study entry - Sites of measurable disease outside the radiotherapy port are available for disease evaluation Surgery - Not specified Other - No prior agents that target epidermal growth factor receptors - No concurrent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, or verapamil) - No concurrent anticoagulants, except for thrombotic events in patients in arm I - No concurrent medications that would alter the pharmacokinetics of gefitinib (e.g., phenytoin, carbamazapine, phenobarbital, rifampin, Hypericum perforatum [St. John's Wort], oxcarbazepine, rifapentine, modafinil, and griseofulvin) - Concurrent bisphosphonates for hypercalcemia or bone metastases are allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertCarlson, Study Chair, Stanford University
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Witold Rybka 717-531-1050
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting John Erban 617-636-5147
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Camilo Fadul 603-650-6312
NSW Breast Cancer Institute *Recruiting*
Westmead, New South Wales, 2145
Australia
Recruiting Michael Barton 61-2-9845-5555
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Theodore Krontiris 626-301-8164
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Howard Hochster 212-652-1912
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
Cancer Institute of New Jersey *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Joseph Aisner 732-235-7464
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Carla Falkson 205-975-2691
Veterans Affairs Medical Center - East Orange *Recruiting*
East Orange, New Jersey, 07019
United States
Recruiting Basil Kasimis 973-676-1000 ext. 1544
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
San Juan City Hospital *Recruiting*
San Juan, , 00936-7344
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Robert Dalton 218-786-8364
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Robert Dreicer 216-445-4623
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus *Recruiting*
Nashville, Tennessee, 37212-2637
United States
Recruiting Kenneth Hande 615-327-4751
Mercy Cancer Center at Mercy Medical Center-Des Moines *Recruiting*
Des Moines, Iowa, 50314
United States
Recruiting Roscoe Morton 515-247-3121
Veterans Affairs Medical Center - Tampa (Haley) *Recruiting*
Tampa, Florida, 33612
United States
Recruiting Julie Kish 813-972-2000
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
Burgess Health Center *Recruiting*
Onawa, Iowa, 51040
United States
Recruiting James Mailliard 712-423-2311
Midlands Cancer Center at Midlands Community Hospital *Recruiting*
Papillion, Nebraska, 68128-4157
United States
Recruiting James Mailliard 402-593-3000
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Joseph Sparano 718-904-2555
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
MBCCOP-Our Lady of Mercy Cancer Center *Recruiting*
Bronx, New York, 10466
United States
Recruiting Peter Wiernik 718-920-1100
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting James Stewart 608-265-8131
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15236
United States
Recruiting John Kirkwood 412-692-4724
Instituto de Enfermedades Neoplasicas *Recruiting*
Lima, , 34
Peru
Recruiting Carlos Vallejos-Sologuren 51-14-499-137
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
Westmead Hospital *Recruiting*
Westmead, New South Wales, 2145
Australia
Recruiting Richard Kefford 61-2-9845-6033
CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver, Colorado, 80224
United States
Recruiting Eduardo Pajon 303-777-2663
Veterans Affairs Medical Center - Brooklyn *Recruiting*
Brooklyn, New York, 11209
United States
Recruiting Andrea Wiesel Leaf 718-630-3691
MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cynthia Cathcart 505-272-5688
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5216
United States
Recruiting Harlan Pinto 650-725-9057
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Daniel Haller 215-662-6318
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Edward Mansour 216-778-4394
Veterans Affairs Medical Center - Miami *Recruiting*
Miami, Florida, 33125
United States
Recruiting Niramol Savaraj 305-324-3143
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting James Lockhart 918-491-5878
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Michael Atkins 617-667-1930
Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita, Kansas, 67218
United States
Recruiting Shaker Dakhil 316-685-2221
Veterans Affairs Medical Center - Omaha *Recruiting*
Omaha, Nebraska, 68105
United States
Recruiting James Mailliard 402-280-5274
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
MBCCOP - San Juan *Recruiting*
San Juan, , 00921-3201
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
Veterans Affairs Medical Center - Indianapolis (Roudebush) *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Patrick Loehrer 317-554-0000
John Stoddard Cancer Center at Iowa Methodist Medical Center *Recruiting*
Des Moines, Iowa, 50309
United States
Recruiting Roscoe Morton 515-241-4245
Veterans Affairs Medical Center - Madison *Recruiting*
Madison, Wisconsin, 53705
United States
Recruiting Mark Albertini 608-262-7017
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
Veterans Affairs Medical Center - Gainesville *Recruiting*
Gainesville, Florida, 32608-1197
United States
Recruiting Dean McCarley 352-374-6016
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting George Adams 612-625-2410
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6307
United States
Recruiting David Johnson 615-343-9454
Veterans Affairs Medical Center - Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15240
United States
Recruiting Timothy Carlos 412-688-6248
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis, Minnesota, 55417-2399
United States
Recruiting Markus Gapany 612-725-2000 ext. 3459
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226-3596
United States
Recruiting David Vesole 414-805-4646
Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago, Illinois, 60611-4494
United States
Recruiting Timothy Kuzel 312-469-3748
Iowa Lutheran Hospital *Recruiting*
Des Moines, Iowa, 50316-2301
United States
Recruiting Roscoe Morton 515-663-5612
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Cancer Answers 800-456-7121
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting William Wood 404-778-5180
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-996-5917
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Veterans Affairs Medical Center - San Juan *Recruiting*
San Juan, , 00927-5800
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
Veterans Affairs Medical Center - Milwaukee (Zablocki) *Recruiting*
Milwaukee, Wisconsin, 53295
United States
Recruiting Mohammed Raheem 414-384-2000
Pretoria Academic Hospital *Recruiting*
Pretoria, , 0001
South Africa
Recruiting Coenraad Slabber 27-12-354-1054
Veterans Affairs Medical Center - Palo Alto *Recruiting*
Palo Alto, California, 94304-1290
United States
Recruiting Harlan Pinto 650-493-5000 ext. 4948
Veterans Affairs Medical Center - Atlanta (Decatur) *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting Maria Amarante Ribeiro 404-728-7680
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Patrick Loehrer 317-278-7418
Drexel University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19102-1192
United States
Recruiting Pamela Crilley 215-762-8547
Veterans Affairs Medical Center - New York *Recruiting*
New York City, New York, 10010
United States
Recruiting Howard Hochster 212-652-1912
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Paul Gilman 610-645-2057
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Lori Goldstein 215-728-2689
Additional Information:
Study ID Numbers: CDR0000285631; ECOG-4101
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057941
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Anastrozole and Gefitinib Compared With Fulvestrant and Gefitinib in Treating Postmenopausal Women With Recurrent or Metastatic Breast Cancer
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