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Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer Clinical research trials and Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer. Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer  Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer
Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer
For Condition: stage 3C breast cancer,stage 1 breast cancer,Male Breast Cancer,stage 2 breast cancer,stage 3A breast cancer
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapyregimen is more effective in treating resected breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of four adjuvant chemotherapy regimens using doxorubicin, cyclophosphamide, and paclitaxel in treating patients who have undergone surgery for stage I, stage II, or stage III breast cancer.
Details: OBJECTIVES: - Compare the disease-free survival of patients with node-positive or high-risk node-negative breast cancer treated with 4 different schedules of adjuvant doxorubicin, cyclophosphamide, and paclitaxel. - Compare the overall survival of patients treated with these regimens. - Compare the toxic effects of these regimens in these patients. - Correlate outcome with putative prognostic markers in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms. - Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses. - Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and filgrastim (G-CSF) SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I. - Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses. - Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III. In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. In all arms, patients with estrogen-receptor or progesterone-receptor positive tumors receive hormonal therapy beginning within 28 days of the completion of adjuvant chemotherapy or radiotherapy (if given). Patients are followed every 6 months for 5 years and then annually for 15 years. PROJECTED ACCRUAL: A total of 4,500 patients (1,125 per treatment arm) will be accrued for this study within 2.25 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage I-III invasive breast cancer - Operable disease - Stage I, II, IIIA, and IIIC (T1-3, N3a only) - No T4 tumors - High-risk disease, defined by 1 of the following: - Node-positive disease, defined by the presence of metastatic breast cancer in 1 or more axillary or intramammary nodes - At least 6 axillary or intramammary nodes must have been histologically examined - Malignant involvement must be detectable by routine pathologic examination with hematoxylin and eosin staining - Patients with immunohistologic staining as the only evidence of nodal involvement are considered node-negative - Node-negative disease AND tumor at least 2 cm - At least 6 nodes must be negative - Node-negative status may be based on removal of fewer than 6 axillary nodes provided sentinel node procedure was performed - Bilateral synchronous breast cancer diagnosed within 1 month of each other allowed provided the higher TNM stage primary tumor meets the eligibility criteria - Prior modified radical mastectomy OR local excision of all tumors with axillary lymph node dissection or sentinel node resection required - No more than 84 days since prior surgery for the primary tumor and/or axilla - Final resection margins for the primary tumor must be histologically negative for invasive cancer and ductal carcinoma in situ - Resection margins positive for lobular carcinoma in situ are allowed - Hormone receptor status: - Estrogen receptor status known - Progesterone receptor status known PATIENT CHARACTERISTICS: Age - 18 and over Sex - Male or female Menopausal status - Not specified Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,200/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than upper limit of normal (ULN) - Alkaline phosphatase no greater than 2 times ULN - SGOT or SGPT no greater than 2 times ULN Renal - Creatinine no greater than ULN Cardiovascular - No congestive heart failure - No angina pectoris - LVEF greater than the lower limit of normal* by MUGA or echocardiogram NOTE: Patients age 60 and over OR with a history of hypertension Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - 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 - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior cytotoxic chemotherapy for this breast cancer - No prior chemotherapy with an anthracycline, anthracenedione, or taxane Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for this malignancy - At least 2 weeks since prior radiotherapy for ductal carcinoma in situ Surgery - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HalleMoore, , Cleveland Clinic Cancer Center
Veterans Affairs Outpatient Clinic - Martinez *Recruiting*
Martinez, California, 94553
United States
Recruiting David Gandara 925-372-2064
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
Veterans Affairs Medical Center - Lexington *Recruiting*
Lexington, Kentucky, 40502-2236
United States
Recruiting Michael Doukas 859-281-4956
CCOP - Beaumont *Recruiting*
Royal Oak, Michigan, 48073-6769
United States
Recruiting David Decker 248-551-7695
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536-0084
United States
Recruiting Michael Doukas 859-257-4500
Veterans Affairs Medical Center - Amarillo *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting William Robinson 806-355-9703
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) *Recruiting*
Phoenix, Arizona, 85012
United States
Recruiting Thomas Kummet 602-277-5551
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cheryl Willman 505-272-5837
University of Tennessee Cancer Institute *Recruiting*
Memphis, Tennessee, 38103
United States
Recruiting Mohammad Jahanzeb 901-722-0532
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
Cancer Research Center of Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Madigan Army Medical Center *Recruiting*
Tacoma, Washington, 98431-5000
United States
Recruiting Patrick Williams 253-968-2505
Veterans Affairs Medical Center - Albuquerque *Recruiting*
Albuquerque, New Mexico, 87108-5138
United States
Recruiting Douglas Clark 505-243-4039
Veterans Affairs Medical Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130
United States
Recruiting Glenn Mills 318-221-8411
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Richard Fisher 585-275-0842
Veterans Affairs Medical Center - Kansas City *Recruiting*
Kansas City, Missouri, 64128
United States
Recruiting Sarah Taylor 816-861-4700 ext. 491
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-241-6251
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Daniel Petrylak 212-305-1731
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0912
United States
Recruiting Laurence Baker 734-936-3983
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
Veterans Affairs Medical Center - Jackson *Recruiting*
Jackson, Mississippi, 39216
United States
Recruiting James Thigpen 601-362-4471
Cancer Research Center at Boston Medical Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Douglas Faller 617-638-8000
Veterans Affairs Medical Center - Memphis *Recruiting*
Memphis, Tennessee, 38104
United States
Recruiting Mohammad Jahanzeb 901-523-8990
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Carolyn Reed 843-792-3362
Veterans Affairs Medical Center - Ann Arbor *Recruiting*
Ann Arbor, Michigan, 48105
United States
Recruiting Laurence Baker 734-769-7100
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Laura Hutchins 501-686-8511
Veterans Affairs Medical Center - Albany *Recruiting*
Albany, New York, 12208
United States
Recruiting James Holland 518-462-3311 ext. 2328
Veterans Affairs Medical Center - Tucson *Recruiting*
Tucson, Arizona, 85723
United States
Recruiting Thomas Miller 520-792-1450 ext. 16631
Veterans Affairs Medical Center - Little Rock (McClellan) *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Bart Barlogie 501-526-2873
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153-5500
United States
Recruiting Patrick Stiff 708-327-3148
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78229-3900
United States
Recruiting Geoffrey Weiss 210-617-5120
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange, California, 92868
United States
Recruiting Randall Holcombe 714-456-5153
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4095
United States
Recruiting Scott Lippman 713-745-3672
Veterans Affairs Medical Center - Temple *Recruiting*
Temple, Texas, 76504
United States
Recruiting Phalguni Mukhopadhyay 254-778-4811 ext. 4809
Veterans Affairs Medical Center - Portland *Recruiting*
Portland, Oregon, 97207
United States
Recruiting Craig Nichols 503-220-8262
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-0269
United States
Recruiting Kim Margolin 626-359-8111
David Grant Medical Center *Recruiting*
Travis Air Force Base, California, 94535
United States
Recruiting David Gandara 707-423-7300
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati, Ohio, 45267-0501
United States
Recruiting Abdul-Rahman Jazieh 513-584-3830
St. Louis University Hospital Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Paul Petruska 314-577-8854
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0565
United States
Recruiting Robert Whitehead 409-772-1164
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Saul Rivkin 206-386-2929
Brooke Army Medical Center *Recruiting*
Fort Sam Houston, Texas, 78234-6200
United States
Recruiting Mitchell Garrison 210-916-0504
Veterans Affairs Medical Center - Salt Lake City *Recruiting*
Salt Lake City, Utah, 84148
United States
Recruiting Wolfram Samlowski 801-582-1565
Harrington Cancer Center *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting James Clarkson 806-359-4673
Veterans Affairs Medical Center - Dayton *Recruiting*
Dayton, Ohio, 45428-1002
United States
Recruiting Howard Gross 937-268-6511
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Kathleen Yost 616-391-1230
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
Tulane University School of Medicine *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Alan Miller 504-587-7566
Veterans Affairs Medical Center - Houston *Recruiting*
Houston, Texas, 77030
United States
Recruiting Gauri Varadhachary 713-791-1414 ext. 5340
Veterans Affairs Medical Center - New Orleans *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Alan Miller 504-589-5250
Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi, Mississippi, 39531-2410
United States
Recruiting Robert Veith 504-568-5151
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97201-3098
United States
Recruiting Craig Nichols 503-494-6346
Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130-3932
United States
Recruiting Glenn Mills 318-675-7639
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting James Thigpen 601-984-5590
Veterans Affairs Medical Center - Oklahoma City *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-270-0501
CCOP - Montana Cancer Consortium *Recruiting*
Billings, Montana, 59101
United States
Recruiting Patrick Cobb 406-259-2245
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-544-1013
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195-9001
United States
Recruiting George Budd 216-444-6480
CCOP - Virginia Mason Research Center *Recruiting*
Seattle, Washington, 98101
United States
Recruiting Andrew Jacobs 206-341-0446
Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tucson, Arizona, 85724
United States
Recruiting Thomas Miller 520-626-2667
CCOP - Bay Area Tumor Institute *Recruiting*
Oakland, California, 94609-3305
United States
Recruiting Joseph Szumowski 510-465-8570
CCOP - Atlanta Regional *Recruiting*
Atlanta, Georgia, 30342-1701
United States
Recruiting Thomas Seay 404-851-2340
Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Thomas Lad 312-996-2046
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Robert Chapman 313-916-1850
Veterans Affairs Medical Center - Cincinnati *Recruiting*
Cincinnati, Ohio, 45220-2288
United States
Recruiting Abdul-Rahman Jazieh 513-861-3100 ext. 6537
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita, Kansas, 67218
United States
Recruiting Shaker Dakhil 316-685-2221
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 - Detroit *Recruiting*
Detroit, Michigan, 48201-1932
United States
Recruiting Lawrence Flaherty 313-576-1000
Veterans Affairs Medical Center - San Antonio (Murphy) *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Geoffrey Weiss 210-617-5120
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112-5550
United States
Recruiting Wolfram Samlowski 801-585-0255
Veterans Affairs Medical Center - Seattle *Recruiting*
Seattle, Washington, 98108
United States
Recruiting William Schubach 206-764-2265
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Heinz-Josef Lenz 323-865-3955
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) *Recruiting*
Hines, Illinois, 60141
United States
Recruiting Nirmala Bhoopalam 708-202-2782
CCOP - Santa Rosa Memorial Hospital *Recruiting*
Santa Rosa, California, 95403
United States
Recruiting Ian Anderson 707-521-3859
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Anthony Elias 720-848-1622
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - St. Louis-Cape Girardeau *Recruiting*
St. Louis, Missouri, 63141
United States
Recruiting Patrick Henry 314-569-6573
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John Roberts 804-828-0450
CCOP - Northwest *Recruiting*
Tacoma, Washington, 98405-0986
United States
Recruiting Lauren Colman 253-403-1461
Providence Cancer Institute at Providence Hospital *Recruiting*
Southfield, Michigan, 48075
United States
Recruiting Anibal Drelichman 313-552-0620
Veterans Affairs Medical Center - Charleston *Recruiting*
Charleston, South Carolina, 29401-5799
United States
Recruiting Carolyn Reed 843-789-7865
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Lawrence Flaherty 313-745-9155
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting John Barstis 310-825-5268
Additional Information:
Study ID Numbers: CDR0000334899; SWOG-S0221
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070564
Other Stage 1 Breast Cancer Studies:
1. Paclitaxel With or Without Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
2. Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
3. Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer
4. Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence
5. CP-724,714 in Treating Patients With Metastatic Breast Cancer
Related Studies:
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Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer
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