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Endocrine |
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Clinical Trial: Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
This study is currently recruiting patients.
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Purpose
RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of ovarian suppression plus either tamoxifen or exemestane with that of tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage I breast cancer stage II breast cancer stage IIIA breast cancer | Drug: exemestane Drug: tamoxifen Drug: triptorelin Procedure: ablative endocrine surgery Procedure: adjuvant therapy Procedure: antiestrogen therapy Procedure: antiprogestational therapy Procedure: aromatase inhibition Procedure: endocrine therapy Procedure: hormone therapy Procedure: oophorectomy Procedure: radiation therapy Procedure: releasing factor agonist therapy | Phase III |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Ovarian Function Suppression in Combination With Tamoxifen Versus Ovarian Function Suppression in Combination With Exemestane Versus Tamoxifen Alone in Premenopausal Women With Endocrine-Responsive Breast Cancer
Further Study Details:
OBJECTIVES:
- Compare ovarian function suppression (by triptorelin, oophorectomy, or ovarian irradiation) in combination with tamoxifen vs ovarian function suppression in combination with exemestane vs tamoxifen alone in patients with endocrine-responsive breast cancer.
- Compare the disease-free and overall survival of patients treated with these regimens.
- Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.
- Compare the incidence of second (nonbreast) malignancies in patients treated with these regimens.
- Compare the sites of first treatment failure in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, prior adjuvant/neoadjuvant chemotherapy (yes vs no), and number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral tamoxifen daily.
- Patients receive tamoxifen as in arm I and ovarian function suppression by 1 of the following treatments:
- Triptorelin intramuscularly once every 28 days
- Surgical oophorectomy
- Ovarian irradiation once daily for 4 or 5 days
- Arm III: Patients receive oral exemestane daily and ovarian function suppression as in arm II. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4 years.
Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 3,000 patients (1,000 per treatment arm) will be accrued for this study within 5 years.
Eligibility
Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Completely resected disease
- No clinically detectable residual loco-regional axillary disease
- Prior surgery for primary breast cancer of 1 of the following types:
- Total mastectomy with or without adjuvant radiotherapy
- Breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins clear of invasive disease and ductal carcinoma in situ) with radiotherapy
- No more than 12 weeks since prior surgery if no adjuvant chemotherapy
- No more than 6 months since prior adjuvant chemotherapy
- Tumor confined to the breast and axillary nodes
- Tumor detected in internal mammary chain nodes that are not enlarged is allowed
- Prior neoadjuvant therapy allowed provided disease was operable prior to neoadjuvant therapy
- Axillary lymph node dissection or a negative axillary sentinel node biopsy required
- Patients with microscopically positive axillary sentinel nodes are eligible if they are randomized in a clinical study evaluating those lymph nodes
- No distant metastases
- No locally advanced inoperable breast cancer, including any of the following:
- Inflammatory breast cancer
- Supraclavicular node involvement
- Enlarged internal mammary nodes (unless pathologically negative)
- No bilateral invasive breast cancer
- No prior ipsilateral or contralateral invasive breast cancer
- Hormone receptor status:
- Estrogen and/or progesterone receptor positive
- At least 10% of the tumor cells positive by immunohistochemistry
PATIENT CHARACTERISTICS: Age
- Premenopausal
Sex
- Female
Menopausal status
- Premenopausal
- Estradiol in the premenopausal range
- Temporary chemotherapy-induced amenorrhea allowed provided premenopausal status is regained within 6 months of the final dose of chemotherapy
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
Renal
- No systemic renal disease that would preclude prolonged follow-up
Cardiovascular
- No systemic cardiovascular disease that would preclude prolonged follow-up
- No prior thrombosis (e.g., deep vein thrombosis) and/or embolism unless patient is medically suitable
Pulmonary
Other
- Not pregnant or nursing
- Fertile patients must use effective nonhormonal contraception
- No history of noncompliance to medical regimens
- No other nonmalignant systemic disease that would preclude prolonged follow-up
- No prior or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or bladder, or contralateral or ipsilateral carcinoma in situ of the breast
- No psychiatric, addictive, or other disorder that would preclude ability to provide informed consent
PRIOR CONCURRENT THERAPY: Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- More than 1 year since prior selective estrogen-receptor modulators (SERMs) before the breast cancer diagnosis
- More than 1 year since prior hormone replacement therapy before the breast cancer diagnosis
- No prior endocrine therapy, including adjuvant or neoadjuvant therapy, for more than 6 months after breast cancer diagnosis
- No prior gonadotropin-releasing hormone analogues for breast cancer
- No concurrent oral or transdermal hormonal therapy
- No other concurrent estrogen, progesterone, or androgens
- No other concurrent aromatase inhibitors
- No concurrent hormone replacement therapy
- No concurrent oral or other hormonal contraceptives (i.e., implants or depot injections)
- No other concurrent SERMs (e.g., raloxifene)
Radiotherapy
- See Disease Characteristics
- No prior ovarian radiotherapy
Surgery
- See Disease Characteristics
- No prior oophorectomy
- No concurrent oophorectomy unless performed as part of this study
Other
- No concurrent bisphosphonates, except in the following cases:
- Bone density is at least 1.5 standard deviations below the young adult normal mean
- Participation in a randomized clinical study testing bisphosphonates in the adjuvant breast cancer setting
- No other concurrent investigational agent
Location and Contact Information
Alabama
East Alabama Medical Center, Opelika, Alabama, 36802-3201, United States; Recruiting
Wesley C. Glisson, MD 334-705-1070 wcg515@msn.com
MBCCOP - Gulf Coast, Mobile, Alabama, 36607, United States; Recruiting
Paul O. Schwarzenberger, MD 251-544-1013
Montgomery Cancer Center, Montgomery, Alabama, 36106-2803, United States; Recruiting
Harry M. Barnes, MD 334-273-2259 hbarnes@aollc.com
Northeast Alabama Regional Medical Center, Anniston, Alabama, 36207, United States; Recruiting
Thomas W. Twele, MD 256-236-2549
Alaska
Alaska Regional Hospital, Anchorage, Alaska, 99508, United States; Recruiting
Richard T. Chung, MD 907-276-2400
Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting
Thomas P. Miller, MD 520-626-2667
Cancer Center of Northern Arizona at Flagstaff Medical Center, Flagstaff, Arizona, 86001, United States; Recruiting
Paul R. Kuefler, MD 928-773-2260
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, 85259-5404, United States; Recruiting
Tom Robert Fitch, MD 480-301-9875
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting
David Kyle King, MD, FACP 602-239-2413 david.king@baannerhealth.com
Mesa Lutheran Hospital, Mesa, Arizona, 85201, United States; Recruiting
Harrison Jay Bachrach, MD 480-985-5331
Sun Health Research Institute, Sun City, Arizona, 85351, United States; Recruiting
Mark A. Benson, MD 623-977-7211
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, 85012, United States; Recruiting
Thomas Dale Kummet, MD 602-277-5551
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, 85723, United States; Recruiting
Harinder S. Garewal, MD 520-629-4686
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
Laura Fulper Hutchins, MD 501-686-8511 LFHutchins@uams.edu
Ben E. Owens Cancer Treatment Center at St. Bernard's Medical Center, Jonesboro, Arkansas, 72403, United States; Recruiting
John K. Lynch, DO 870-972-4510 j-klynch@ipa.net
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center, Fort Smith, Arkansas, 72913, United States; Recruiting
Tony A. Flippin, MD 479-484-4700
Highlands Oncology Group - Fayetteville, Fayetteville, Arkansas, 72703, United States; Recruiting
Daniel S. Bradford, MD 479-587-1700
Jefferson Regional Medical Center, Pine Bluff, Arkansas, 71603, United States; Recruiting
Omar Atiq, MD, FACP 870-535-2800
North Arkansas Regional Medical Center, Harrison, Arkansas, 72601, United States; Recruiting
Ali Abdelaal, MD 870-365-0223
Sparks Regional Medical Center, Fort Smith, Arkansas, 72917-7006, United States; Recruiting
Lester Ford Barnes, MD 501-709-7435
Veterans Affairs Medical Center - Little Rock, Little Rock, Arkansas, 72205, United States; Recruiting
Bart Barlogie, MD 501-526-2873
California
California Cancer Center - Woodward Park Office, Fresno, California, 93720, United States; Recruiting
Luther D. Glenn, MD 559-447-3456
CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States; Recruiting
Joseph Szumowski, MD 510-465-8570
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, 95403, United States; Recruiting
Ian C. Anderson, MD 707-521-3830
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868, United States; Recruiting
Randall F. Holcombe, MD 714-456-5153 rholcomb@uci.edu
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
Clinical Trials Office - New Patient Services 800-826-4673 becomingapatient@coh.org
Comprehensive Cancer Center at Desert Regional Medical Center, Palm Springs, California, 92262-5309, United States; Recruiting
Elber S. Camacho, MD 760-416-4880 ecamacho@salick.com
Crosson Cancer Center at St. Jude Medical Center, Fullerton, California, 92835, United States; Recruiting
Case Henri Ketting, MD 714-446-5632
Doctors Medical Center, Modesto, California, 95350-4138, United States; Recruiting
Mussa Banisadre, MD 209-576-3667
General Robert Huyser Cancer Center at David Grant Medical Center, Travis Air Force Base, California, 94535, United States; Recruiting
Kevin P. Ryan, MD 707-423-5129 ryan_k@comcast.net
Glendale Memorial Hospital Comprehensive Cancer Center, Glendale, California, 91204, United States; Recruiting
Mercedes Brenneisen, MD, FACP 818-553-8160
Huntington Cancer Center at Huntington Hospital, Pasadena, California, 91105, United States; Recruiting
David M. Faddis, MD 626-535-2425
John Muir Comprehensive Cancer Center at John Muir Medical Center, Walnut Creek, California, 94598, United States; Recruiting
Howard D. Maccabee, PhD, MD 925-947-3250
John Wayne Cancer Institute at Saint John's Health Center, Santa Monica, California, 90404, United States; Recruiting
Peter David Boasberg, MD 310-582-7900
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-6900, United States; Recruiting
Patricia A. Ganz, MD 310-206-1404 pganz@ucla.edu
Kaiser Permanente Medical Center - Sacramento, Sacramento, California, 95825, United States; Recruiting
Jesse William Adams, MD 916-973-5259
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, 92354, United States; Recruiting
Jesus G. Berdeja, MD 909-558-4910
Los Angeles Oncologic Institute, Los Angeles, California, 90057, United States; Recruiting
Peter S. Kennedy, MD 213-484-6474
Mercy Regional Cancer Center at Mercy Medical Center, Redding, California, 96049, United States; Recruiting
C. Gregg Carter, MD 530-225-7471
Methodist Hospital of Southern California, Arcadia, California, 91066-6016, United States; Recruiting
Benjamin T. Stafford, MD 626-574-3515
Naval Medical Center - San Diego, San Diego, California, 92134-3202, United States; Recruiting
Preston Gable, MD 619-532-7303 pgable@nmcsd.med.navy.mil
North Bay Cancer Center, Fairfield, California, 94533, United States; Recruiting
James M. Long, MD 707-429-6989 jlong@northbay.org
Northridge Hospital, Northridge, California, 91324, United States; Recruiting
Lisa Chaiken, MD 818-990-5020
Presbyterian Intercommunity Hospital, Whittier, California, 90602, United States; Recruiting
Tzann-Tarn Fang, MD 562-320-1234
Providence Saint Joseph Medical Center - Burbank, Burbank, California, 91505, United States; Recruiting
Arnold W. Malcolm, MD 818-843-5111 ext. 7420 amalcolm@phsla.org
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, 92093-0658, United States; Recruiting
Stephen L. Seagren, MD 619-543-5303
Redding Cancer Treatment Center, Redding, California, 96001, United States; Recruiting
Vidya Sagar Bobba, MD 530-245-5900 dr.bobba@reddingcancertreatment.com
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States; Recruiting
Alan T. Lefor, MD 310-423-5874 Alan.Lefor@cshs.org
Sansum Medical Clinic, Santa Barbara, California, 93105, United States; Recruiting
Mark Abate, MD 805-898-3270
Scripps Cancer Center at Scripps Clinic, La Jolla, California, 92037, United States; Recruiting
Richard G. Just, MD 858-882-8301 just.richard@scrippshealth.org
Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital, Grass Valley, California, 95945, United States; Recruiting
David L. Campbell, MD 530-274-6677 campbell@grassvalleyoncology.com
St. Joseph Hospital Regional Cancer Center - Orange, Orange, California, 92868-3849, United States; Recruiting
Brian A. Palafox, MD 714-639-8320 idorcd@aol.com
St. Joseph's Regional Cancer Center, Stockton, California, 95204, United States; Recruiting
Aminder S. Mehdi, MD 209-941-0217
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, 94305-5750, United States; Recruiting
Steven E. Coutre, MD 650-723-5007 coutre@stanford.edu
Sutter Cancer Center, Sacramento, California, 95816, United States; Recruiting
Vincent Caggiano, MD 916-454-6500 caggiav@sutterhealth.org
Sutter Health Western Division Cancer Research Group, Greenbrae, California, 94904, United States; Recruiting
Ari D. Baron, MD 415-923-3012
UCSF Comprehensive Cancer Center, San Francisco, California, 94115, United States; Recruiting
Alan Paul Venook, MD 800-888-8664 venook@cc.ucsf.edu
University of California Davis Cancer Center, Sacramento, California, 95817, United States; Recruiting
David R. Gandara, MD 916-734-3772 dgandara@cc.ucdmc.ucdavis.edu
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033, United States; Recruiting
Heinz-Josef Lenz, MD 323-865-3955 lenz@usc.edu
Veterans Affairs Medical Center - San Diego, San Diego, California, 92161, United States; Recruiting
Saeeda Kirmani, MD 619-552-8585 ext. 3356 skirmani@ucsd.edu
Veterans Affairs Medical Center - San Francisco, San Francisco, California, 94121, United States; Recruiting
Patricia A. Cornett, MD 415-221-4810 ext. 3423 patricia.cornett@med.va.gov
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, 94553, United States; Recruiting
David R. Gandara, MD 925-372-2064
Colorado
Exempla Lutheran Medical Center, Wheat Ridge, Colorado, 80033, United States; Recruiting
Jennifer H. Caskey, MD 303-425-4500
Memorial Hospital Cancer Center, Colorado Springs, Colorado, 80909, United States; Recruiting
David Scott Brantley, MD 719-365-5000
Poudre Valley Hospital, Fort Collins, Colorado, 80524, United States; Recruiting
Michael P. Fangman, MD, FACP 970-493-6337
St. Anthony Central Hospital, Denver, Colorado, 80204-1335, United States; Recruiting
Jennifer H. Caskey, MD 303-315-3011
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center, Grand Junction, Colorado, 81502-1628, United States; Recruiting
Amir Z. Beshai, MD 970-243-3061
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, 80010, United States; Recruiting
Anthony D. Elias, MD 720-848-1622 Anthony.Elias@uchsc.edu
Veterans Affairs Medical Center - Denver, Denver, Colorado, 80220, United States; Recruiting
Madeleine A. Kane, MD, PhD 303-399-8020 ext. 3129 madeleine.kane@med.va.gov
Connecticut
St. Vincent's Medical Center, Bridgeport, Connecticut, 06606, United States; Recruiting
Seyed H. Aleali, MD, FACP 203-255-4545
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
Stephen Scott Grubbs, MD 302-623-4100
District of Columbia
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, 20007, United States; Recruiting
Edward P. Gelmann, MD 202-444-7303 gelmanne@georgetown.edu
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, 20060, United States; Recruiting
Lucile L. Adams-Campbell, PhD 202-806-7697
Walter Reed Army Medical Center, Washington, District of Columbia, 20307-5001, United States; Recruiting
Thomas Joseph Reid, MD, PhD, FACP 202-782-5762 thomas.reid@na.amedd.army.mil
Florida
Bethesda/South Florida Bone Marrow Stem Cell Transplant Institute, Boynton Beach, Florida, 33437-3750, United States; Recruiting
Dipnarine Maharaj, MB, ChB, MD, FACP 561-752-5522 dmaharaj@bmscti.org
Broward General Medical Center, Fort Lauderdale, Florida, 33316, United States; Recruiting
Luis Ramon Barreras, MD, FACP 954-771-0692
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States; Recruiting
Rogerio C. Lilenbaum, MD 305-674-2625
Florida Hospital Cancer Institute, Orlando, Florida, 32804, United States; Recruiting
Jane Crofton, RN, BSN, OCN 407-303-2090
Hematology Oncology Associates, Lake Worth, Florida, 33461, United States; Recruiting
Eduardo A. Garcia, MD 561-965-1864 doceag@bellsouth.net
JFK Medical Center, Atlantis, Florida, 33462, United States; Recruiting
Neil S. Friedman, MD 561-439-4682
Mayo Clinic - Jacksonville, Jacksonville, Florida, 32224, United States; Recruiting
Edith A. Perez, MD 904-953-7283 perez.edith@mayo.edu
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, 33021, United States; Recruiting
Atif M. Hussein, MD 954-986-6363
Palm Beach Cancer Institute - West Palm Beach, West Palm Beach, Florida, 33401, United States; Recruiting
Robert J. Jacobson, MB, ChB, FACP, FRCP(C) 561-366-4150
Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida, 32504, United States; Recruiting
Joanne L. Bujnoski, DO 850-416-6700 jbujnosk@shhpens.org
University Community Hospital, Tampa, Florida, 33613, United States; Recruiting
Marc B. Bloom, MD 813-910-0027
University of Florida Shands Cancer Center, Gainesville, Florida, 32610-0277, United States; Recruiting
Barbara Shea, MD 352-392-2995 sheabf@medicine.ufl.edu
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting
Raoul R. Salup, MD 813-972-7579 raoul.salup@med.va.gov
West Florida Cancer Institute - Pensacola, Pensacola, Florida, 32514, United States; Recruiting
Mark S. Boatright, MD 850-474-8382
Georgia
Augusta Oncology Associates, Augusta, Georgia, 30901, United States; Recruiting
Miriam J. Atkins, MD 706-821-2944 miratkins@aol.com
CCOP - Atlanta Regional, Atlanta, Georgia, 30342-1701, United States; Recruiting
Thomas E. Seay, MD, PhD 404-851-2340
Dwight David Eisenhower Army Medical Center, Fort Gordon, Georgia, 30905-5650, United States; Recruiting
Kenneth I. Fink, MD 706-787-2527 kenneth.fink@se.amedd.army.mil
Northeast Georgia Medical Center, Gainesville, Georgia, 30501-3741, United States; Recruiting
Jack Thurmon Griffeth, MD 770-535-3393 jack.griffeth@nghs.com
Pearlman Comprehensive Cancer Center at South Georgia Medical Center, Valdosta, Georgia, 31602, United States; Recruiting
Jeffrey M. Hoy, MD 229-259-4628 jeffrey.hoy@sgmc.org
Phoebe Cancer Center at Phoebe Putney Memorial Hospital, Albany, Georgia, 31701, United States; Recruiting
Robert F. Krywicki, MD 229-312-0344 ahwillia@ppmh.org
Hawaii
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
William S. Loui, MD, FACP 808-524-6115 wsloui@hotmail.com
Idaho
Hematology Oncology Associates of Eastern Idaho, Idaho Falls, Idaho, 83404, United States; Recruiting
Kevin P. Mulvey, MD 208-552-1410 kmulveymd@ida.net
St. Luke's Regional Medical Center, Boise, Idaho, 83712, United States; Recruiting
Thomas M. Beck, MD 208-381-2737
Illinois
BroMenn Regional Medical Center, Normal, Illinois, 61761, United States; Recruiting
Hwan G. Jeong, MD 309-452-9701
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, 60153-5500, United States; Recruiting
Patrick J. Stiff, MD 708-327-3148
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States; Recruiting
Kendrith M. Rowland, MD 217-383-4083 kendrith.rowland@carle.com
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
James L. Wade, MD 217-876-6617 jlwade3@sbcglobal.net
CCOP - Evanston, Evanston, Illinois, 60201, United States; Recruiting
Gershon Y. Locker, MD, FACP 847-570-2518 glocker@enh.org
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615-7828, United States; Recruiting
John W. Kugler, MD 309-243-3605
Center for Cancer Care at OSF Saint Anthony Medical Center, Rockford, Illinois, 61108, United States; Recruiting
Richard E. Nora, MD 815-227-2273 richard.nora@osfhealthcare.org
Hematology Oncology Consultants Ltd., Naperville, Illinois, 60540, United States; Recruiting
Dennis Lloyd Azuma, MD 630-369-1501
La Grange Oncology Associates, La Grange, Illinois, 60525, United States; Recruiting
Renee H. Jacobs, MD 708-579-3418 rjacobs@lagrangeoncology.com
Louis A. Weiss Memorial Hospital, Chicago, Illinois, 60640, United States; Recruiting
Keith L. Shulman, MD 773-564-5022 KShulman@weisshospital.org
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-335-3614
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, 60611, United States; Recruiting
David A. Fishman, MD 312-926-7365
Saint Mary's Hospital, Centralia, Illinois, 62801, United States; Recruiting
James E. Hays, MD 618-533-5000
University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States; Recruiting
Karen Wendling 773-834-7424
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-569-6129
Veterans Affairs Medical Center - Hines, Hines, Illinois, 60141, United States; Recruiting
Nirmala Bhoopalam, MD 708-202-2782
West Suburban Center for Cancer Care, River Forest, Illinois, 60305, United States; Recruiting
John L. Showel, MD 708-763-2700 doc.shoj@wsmc.org
Indiana
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601, United States; Recruiting
Rafat H. Ansari, MD, FACP 574-284-7977
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, 46885-5099, United States; Recruiting
Sreenivasa Rao Nattam, MD 260-484-8830 ledgar@fwmoh.com
Iowa
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, 52403-1206, United States; Recruiting
Martin Wiesenfeld, MD 319-363-8303
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, 50309-1016, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-244-7586
Genesis Regional Cancer Center at Genesis Medical Center, Davenport, Iowa, 52803, United States; Recruiting
Brahma R. Konda, MD 363-323-4612 brahmak@hotmail.com
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1009, United States; Recruiting
Gerald H. Clamon, MD 319-356-8110
Siouxland Hematology-Oncology, Sioux City, Iowa, 51101-1733, United States; Recruiting
Donald Bruce Wender, MD, PhD 712-252-0088 shoaresearch@shoa-research.org
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-268-5784
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, 66160-7353, United States; Recruiting
Sarah A. Taylor, MD 913-588-6029 sataylor@kumc.edu
Salina Regional Health Center, Salina, Kansas, 67401, United States; Recruiting
Larry K. Beck, MD 913-827-7261
St. Francis Comprehensive Cancer Center, Topeka, Kansas, 66606, United States; Recruiting
Edwin L. Petrik, MD 785-354-9591
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-685-2221
Kentucky
Baptist Hospital East - Louisville, Louisville, Kentucky, 40207, United States; Recruiting
Daniel C. Scullin, MD 502-897-1166
Cancer Care at Our Lady of Bellefonte Hospital, Ashland, Kentucky, 41101, United States; Recruiting
Kirti K. Jain, MD 606-836-0202
Central Baptist Hospital, Lexington, Kentucky, 40503, United States; Recruiting
Lee G. Hicks, MD 859-276-0414
James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky, 40202, United States; Recruiting
Leela Bhupalam, MD 502-562-4247
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0084, United States; Recruiting
Michael A. Doukas, MD 859-257-3379
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, 40502-2236, United States; Recruiting
Michael A. Doukas, MD 859-281-4956
Louisiana
Cancer Center at Thibodaux Regional Medical Center, Thibodaux, Louisiana, 70302-1118, United States; Recruiting
James K. Ellis, MD 985-493-4334
Cancer Treatment Center at Christus Schumpert St. Mary Place, Shreveport, Louisiana, 71101-0000, United States; Recruiting
Anirudha Dasgupta, MD, FACP 318-681-4218
CCOP - Ochsner, New Orleans, Louisiana, 70121, United States; Recruiting
Carl G. Kardinal, MD 504-842-3910
Christus St. Frances Cabrini Center for Cancer Care, Alexandria, Louisiana, 71301, United States; Recruiting
Lawrence P. Menache, MD 318-448-6917 lpmenache@aol.com
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, 71130-3932, United States; Recruiting
Glenn M. Mills, MD 318-675-5970 gmills@lsuhsc.edu
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Jill Gilbert, MD 504-568-5613 jgilbe@lsuhsc.edu
New Orleans Cancer Institute At Memorial Medical Center, New Orleans, Louisiana, 70115, United States; Recruiting
Patricia S. Braly, MD 504-897-5869
Our Lady of Lourdes Regional Medical Center, Lafayette, Louisiana, 70502-4027, United States; Recruiting
Joseph Eugene Brierre, MD 318-235-7898
Rapides Regional Medical Center, Alexandria, Louisiana, 71301-7888, United States; Recruiting
Howard Gilbert Wold, MD 318-448-6522
Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, 70112, United States; Recruiting
Alan M. Miller, MD, PhD 504-587-7566 amiller@tulane.edu
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, 70112, United States; Recruiting
German S. Beltran, MD 504-588-5482
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, 71101-4295, United States; Recruiting
Glenn M. Mills, MD 318-221-8411
Willis-Knighton Cancer Center at Willis-Knighton Medical Center, Shreveport, Louisiana, 71103-3951, United States; Recruiting
Lane R. Rosen, MD 318-212-4639
Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, 21225, United States; Recruiting
Fouad M. Abbas, MD 410-601-9030
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, 21201, United States; Recruiting
Martin J. Edelman, MD 410-328-2703 medelman@umm.edu
St. Joseph Medical Center, Towson, Maryland, 21204, United States; Recruiting
Paul Chang, MD 410-337-4521
Massachusetts
Berkshire Hematology Oncology, P.C., Pittsfield, Massachusetts, 01201, United States; Recruiting
Michael Joseph DeLeo, MD 413-443-6000 michael.deleo@usoncology.com
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Michael Benjamin Atkins, MD 617-667-1930
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, 02118, United States; Recruiting
Douglas V. Faller, MD, PhD 617-638-4173
Caritas Holy Family Hospital, Methuen, Massachusetts, 01844, United States; Recruiting
Pedro M. Sanz-Altamira, MD 978-685-7811
Caritas St. Elizabeth's Medical Center, Boston, Massachusetts, 02135, United States; Recruiting
Timothy M. Anderson, MD 617-562-7954
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
George P. Canellos, MD 617-632-3470 george_canellos@dfci.harvard.edu
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, 01655, United States; Recruiting
Pankaj Bhargava 508-856-6884 bhargavp@ummhc.org
Michigan
Alpena General Hospital, Alpena, Michigan, 49707, United States; Recruiting
Robert Leslie Donnell, MD 989-356-7353 donnellrl@hotmail.com
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States; Recruiting
Lawrence E. Flaherty, MD 313-745-9155 flaherty@karmanos.org
Bay Regional Medical Center, Bay City, Michigan, 48708, United States; Recruiting
Jonathan D. Abramson, MD 989-893-3551
Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan, 48910, United States; Recruiting
Madan L. Arora, MD 810-235-8569
CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States; Recruiting
Jeanne Archer, PhD, APN 248-551-8299 carcher@beaumon.edu
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting
Kathleen Jo Yost, MD 616-391-1230
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Philip J. Stella, MD 734-712-5237
Detroit Medical Center at Wayne State University, Detroit, Michigan, 48201, United States; Recruiting
Thomas S. Siegel, MD 313-593-0810
Foote Hospital, Jackson, Michigan, 49201, United States; Recruiting
John A. Axelson, MD 517-789-7122
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
Robert Anthony Chapman, MD 313-916-1332 rchapma1@hfhs.org
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan, 49085, United States; Recruiting
Cynthia Bender, BA, CRA 269-985-4516 cbender@lakelandregional.org
Mount Clemens General Hospital, Mount Clemens, Michigan, 48043, United States; Recruiting
Mark J.R. Fireman, MD 586-776-4820 firemanmar@aol.com
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, 48123-2500, United States; Recruiting
Edmund M. Barbour, MD 313-593-8090
Providence Cancer Institute at Providence Hospital - Southfield, Southfield, Michigan, 48075, United States; Recruiting
Anibal Drelichman, MD, MPH, FACP 313-552-0620 adrelichman@yahoo.com
St. Joseph Mercy Hospital, Pontiac, Michigan, 48341-2985, United States; Recruiting
Patricia A. Ball, MD 248-360-8244
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0948, United States; Recruiting
Laurence H. Baker, DO, FACOI 734-936-3983 bakerl@umich.edu
Upper Michigan Cancer Center at Marquette General Hospital, Marquette, Michigan, 49855, United States; Recruiting
Daniel J. Arnold, MD 906-632-6013
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, 48201-1932, United States; Recruiting
Lawrence E. Flaherty, MD 313-576-1000
Minnesota
CCOP - Duluth, Duluth, Minnesota, 55805, United States; Recruiting
Daniel Nikcevich, MD, PhD 218-786-3625 dnikcevich@smdc.org
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States; Recruiting
Patrick J. Flynn, MD 952-993-1517 patrick.flynn@usoncology.com
Coborn Cancer Center, Saint Cloud, Minnesota, 56303, United States; Recruiting
Harold E. Windschitl, MD 320-229-5199 windschitlh@centracare.com
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
James N. Ingle, MD 507-284-8432 ingle.james@mayo.edu
University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting
Bruce A. Peterson, MD 612-624-5631
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, 55417, United States; Recruiting
Vicki A. Morrison, MD 612-467-4135 morri002@tc.umn.edu
Mississippi
Keesler Medical Center - Keesler Air Force Base, Keesler AFB, Mississippi, 39534-2576, United States; Recruiting
John Bomalaski, MD 228-377-6396 john.bomalaski@keesler.af.mil
Medical Oncology Group, P.A., Gulfport, Mississippi, 39501, United States; Recruiting
Edwin M. Davidson, MD 228-864-3000
Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, 39581, United States; Recruiting
John D. Bailey, MD 228-762-3147
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting
James Tate Thigpen, MD 601-984-5590 jthigpen@medicine.umsmed.edu
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, 39216, United States; Recruiting
James Tate Thigpen, MD 601-362-4471
Missouri
Audrain Medical Center, Mexico, Missouri, 65265, United States; Recruiting
Shahid Waheed, MD 573-582-4100
Cancer Care Central Missouri, Sedalia, Missouri, 65301, United States; Recruiting
Prakash C. Neupane, MD 660-829-7792 pneupane@brhc.org
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting
John Wendall Goodwin, MD 417-269-4520 jwg684@sprg.mercy.net
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
William T. Stephenson, MD 816-823-0555
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, 63141, United States; Recruiting
Bethany G. Sleckman, MD 314-569-6573
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, 65203, United States; Recruiting
Michael C. Perry, MD 573-882-4979 perrym@health.missouri.edu
Missouri Baptist Cancer Center, Saint Louis, Missouri, 63131, United States; Recruiting
Alan Philip Lyss, MD 314-996-5514 alyss@bjc.org
Saint Louis University Cancer Center, Saint Louis, Missouri, 63110, United States; Recruiting
Paul J. Petruska, MD 314-268-5451 petruspj@slu.edu
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States; Recruiting
Nancy L. Bartlett, MD 314-362-4843
Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, 65201, United States; Recruiting
William P. Patterson, MD 573-882-6163
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, 64128, United States; Recruiting
Peter J. VanVeldhuizen, MD 816-861-4700 ext. 6775 peter.vanveldhuizen@med.va.gov
Montana
CCOP - Montana Cancer Consortium, Billings, Montana, 59101, United States; Recruiting
Patrick W. Cobb, MD 406-259-2245
Nebraska
Cancer Center at the Good Samaritan Health Systems, Kearney, Nebraska, 68848-1990, United States; Recruiting
George K. Bascom, MD 308-865-7564 georgeb51@hotmail.com
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-7680, United States; Recruiting
Margaret Anne Kessinger, MD 402-559-7511 makessin@unmc.edu
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting
John Allan Ellerton, MD, CM 702-384-0013 k.vanwagenen@sncrf.org
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Web site for additional information
Study ID Numbers: CDR0000316456; IBCSG-24-02; BIG-2-02; CALGB-IBCSG-24-02; CAN-NCIC-IBCSG-24-02; NCCTG-IBCSG-24-02; NSABP-IBCSG-24-02; SWOG-IBCSG-24-02; NABCI-IBCSG-24-02; UCLA-0403024-01; EU-20334; NCT00066690
Record last reviewed: March 2005
Last Updated: March 28, 2005
Record first received: August 6, 2003
ClinicalTrials.gov Identifier: NCT00066690
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: March 2005
Last Updated: March 28, 2005
Record first received: August 6, 2003
ClinicalTrials.gov Identifier: NCT00066690
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Aromatherapy for the Glandular System (HealthWorld)
- Disorders of the Endocrine System (HealthWorld)
