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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer

Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer



Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer

For Condition: stage 3A breast cancer,stage 3B breast cancer,stage 2 breast cancer,stage 1 breast cancer
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada , North Central Cancer Treatment Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as epoetin alfa and filgrastim may decrease the side effects of chemotherapy. It is not yet known which treatment regimen is most effective for breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of combination chemotherapy given with or without epoetin alfa in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
Details: OBJECTIVES: - Compare the disease-free survival and overall survival of premenopausal or early postmenopausal women with previously resected node positive or high-risk node negative stage I-IIIB breast cancer treated with cyclophosphamide, epirubicin, and fluorouracil vs cyclophosphamide, epirubicin, filgrastim (G-CSF), and epoetin alfa followed by paclitaxel vs cyclophosphamide and doxorubicin followed by paclitaxel. - Compare the rate of toxic effects of these regimens in this patient population. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (0 vs 1-3 vs 4-10 vs more than 10), type of prior surgery (total vs partial mastectomy), and estrogen receptor status (positive vs negative). Patients are randomized to one of three treatment arms. - Arm I: Patients receive epirubicin IV and fluorouracil IV on days 1-8 and oral cyclophosphamide on days 1-14. Treatment repeats every 28 days for 6 courses. - Patients receive epirubicin IV and cyclophosphamide IV on day 1 and filgrastim (G-CSF) subcutaneously (SC) on days 2-13. Patients also receive epoetin alfa SC once weekly beginning within 1 week after start of therapy and continuing (as needed) until completion of therapy. Treatment repeats every 14 days for 6 courses. Beginning 21 days after completion of epirubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and G-CSF and epoetin alfa as above. Treatment repeats every 21 days for 4 courses. - Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 15 minutes on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel as in arm II. Treatment in all arms continues in the absence of disease progression or unacceptable toxicity. All receptor positive patients receive oral tamoxifen or anastrozole (if tamoxifen is contraindicated) for 5 years after completion of chemotherapy. Quality of life is assessed at baseline, weeks 4, 8, 12, and 20 (arm I), weeks 4, 8, 13, and 22 (arm II), weeks 3, 9, 12, and 21 (arm III), 9 months, 12 months, and then annually thereafter. Patients are followed at 9 months, 12 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,500 patients (500 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /60 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the breast that is potentially curable - T0-4 (dermal involvement on pathology assessment only), N0-2, M0 - No clinical T4 disease - Previously treated with one of the following: - Total mastectomy and level II axillary node dissection - Partial mastectomy and axillary node dissection with planned breast radiotherapy after completion of study (if microscopic residual in situ or invasive disease is present at partial mastectomy margins, planned radiotherapy must also include a boost to the tumor bed) - Sentinel node biopsy (if node positive, must undergo level II axillary node dissection) - No residual tumor in the axilla after dissection - Axillary node positive or high-risk node negative after level II axillary node dissection - Negative nodes allowed if tumor at least 1 cm and one or more of the following is present: - Histological grade III - Estrogen receptor negative - Lymphatic/vascular invasion - Hormone receptor status: - Estrogen receptor status known PATIENT CHARACTERISTICS: Age: - 60 and under Sex: - Female Menopausal status: - Pre- or postmenopausal Performance status: - ECOG 0-2 Life expectancy: - At least 5 years Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - LVEF at least lower limit of normal by MUGA or echocardiogram - No arrhythmia requiring ongoing treatment - No congestive heart failure - No documented coronary artery disease Other: - No other malignancy except: - Adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - Ductal or lobular carcinoma in situ that has been curatively treated by surgery alone - Other prior malignancies (except breast cancer) curatively treated more than 5 years prior to study - No serious underlying medical illness or psychiatric or addictive disorder that would preclude study - No known hypersensitivity to E. coli-derived products, mammalian-cell derived products, or any study agents - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective non-hormonal contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy for breast cancer Chemotherapy: - No prior chemotherapy for breast cancer Endocrine therapy: - No prior hormonal therapy for breast cancer - No concurrent hormone replacement therapy - No concurrent selective estrogen-receptor modulators (e.g., raloxifene for the treatment or prevention of osteoporosis) - No concurrent oral contraceptives (i.e., birth control pills) - No other concurrent aromatase inhibitors Radiotherapy: - See Disease Characteristics - No prior radiotherapy for breast cancer Surgery: - See Disease Characteristics - No more than 12 weeks since prior total or partial mastectomy (including re-excision of margins) Other: - At least 30 days since prior investigational drugs - No other concurrent investigational drugs - Concurrent bisphosphonates for the treatment or prevention of osteoporosis allowed
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
EdithPerez,  Study Chair,  Mayo Clinic

Graves-Gilbert Clinic *Recruiting*
Bowling Green,  Kentucky,  42102-9007
United States
Recruiting Thomas  Young 270-783-3369

Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton,  Ontario,  L8V 5C2
Canada
Recruiting Mark  Levine 905-527-4322, ext. 42176

Green Cancer Center at Scripps Clinic *Recruiting*
La Jolla,  California,  92037
United States
Recruiting Richard  Just 858-882-8301

St. Luke's Hospital *Recruiting*
Duluth,  Minnesota,  55805
United States
Recruiting Tanya  Repka 218-726-3081

Creighton University Medical Center *Recruiting*
Omaha,  Nebraska,  68131-2197
United States
Recruiting Peter  Silberstein 402-280-3432

Saskatoon Cancer Centre *Recruiting*
Saskatoon,  Saskatchewan,  S7N 4H4
Canada
Recruiting Deepu  Mirchandani 306-655-2690

Lawrence M. Stallings Medical Practice *Recruiting*
Wooster,  Ohio,  44691
United States
Recruiting Lawrence  Stallings 330-262-2800

St. Joseph's Health Centre - Toronto *Recruiting*
Toronto,  Ontario,  M6R 1B5
Canada
Recruiting John  Blondal 416-530-6586

University of Minnesota Cancer Center *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting Douglas  Yee 612-625-3636

CCOP - Toledo Community Hospital *Recruiting*
Toledo,  Ohio,  43623-3456
United States
Recruiting Paul  Schaefer 419-843-6147

Kingston Regional Cancer Centre *Recruiting*
Kingston,  Ontario,  K7L 5P9
Canada
Recruiting Yolanda  Madarnas 613-544-2631

Willis - Knighton South Center for Women's Health *Recruiting*
Shreveport,  Louisiana,  71118
United States
Recruiting Robert  Nickelson 318-632-5165

Central Baptist Hospital *Recruiting*
Lexington,  Kentucky,  40503
United States
Recruiting Lee  Hicks 859-260-6065

Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London,  Ontario,  N6A 4L6
Canada
Recruiting Theodore  Vandenberg 519-685-8640

CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale,  Arizona,  85259-5404
United States
Recruiting Tom  Fitch 480-301-9875

Lynn Regional Cancer Center West *Recruiting*
Boca Raton,  Florida,  33466
United States
Recruiting Peter  Radice 561-883-7600

Evansville Cancer Center *Recruiting*
Evansville,  Indiana,  47715
United States
Recruiting Rick  Ballou 812-474-1110

Peterborough Oncology Clinic *Recruiting*
Peterborough,  Ontario,  K9H 7B6
Canada
Recruiting Rafal  Wierzbicki 905-576-8711 ext. 4044

Ivinson Memorial Hospital *Recruiting*
Laramie,  Wyoming,  82070
United States
Recruiting Charles  Tweedy 307-742-2141

Toronto General Hospital *Recruiting*
Toronto,  Ontario,  M5G 2C4
Canada
Recruiting John  Gapski 905-848-7160

Allan Blair Cancer Centre *Recruiting*
Regina,  Saskatchewan,  S4T 7T1
Canada
Recruiting Haji  Chalchal 306-766-2691

Ottawa Regional Cancer Centre *Recruiting*
Ottawa,  Ontario,  K1H 1C4
Canada
Recruiting Susan  Dent 613-737-770 ext. 56760

Suburban Hospital Cancer Program *Recruiting*
Bethesda,  Maryland,  20817
United States
Recruiting Cheryl  Aylesworth 301-897-1503

Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto,  Ontario,  M4N 3M5
Canada
Recruiting Kathleen  Pritchard 416-480-4616

Arlington-Fairfax Hematology/Oncology, PC *Recruiting*
Arlington,  Virginia,  22205
United States
Recruiting John  Feigert 703-528-7303

Cancer Treatment Center *Recruiting*
Shreveport,  Louisiana,  71101-0000
United States
Recruiting Laura  Campbell 318-681-4121

Mount Sinai Hospital - Toronto *Recruiting*
Toronto,  Ontario,  M5G 1X5
Canada
Recruiting Martin  Blackstein 416-586-5371

Sparks Regional Medical Center *Recruiting*
Fort Smith,  Arkansas,  72901-2418
United States
Recruiting Lester  Barnes 479-709-7435

Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville,  Florida,  32610-0277
United States
Recruiting Barbara  Shea 352-392-2995

Sibley Memorial Hospital *Recruiting*
Washington D.C.,  District of Columbia,  20016
United States
Recruiting Frederick  Smith 202-537-4923

Maine Center for Cancer Medicine and Blood Disorders - Scarborough *Recruiting*
Scarborough,  Maine,  04074
United States
Recruiting Tracey  Weisberg 207-885-7600

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

Nanaimo Cancer Clinic at Nanaimo Regional General Hospital *Recruiting*
Nanaimo,  British Columbia,  V9S 2B7
Canada
Recruiting Christopher  Williams 250-755-7691 ext. 2784

CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha,  Nebraska,  68106
United States
Recruiting James  Mailliard 402-280-4364

St. Michael's Hospital - Toronto *Recruiting*
Toronto,  Ontario,  M5B 1W8
Canada
Recruiting Rashida  Haq 416-864-5912

Consultants in Blood Disorders and Cancer *Recruiting*
Louisville,  Kentucky,  40207
United States
Recruiting Daniel  Scullin 502-897-1166

James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester,  New York,  14642
United States
Recruiting Jennifer  Griggs 585-275-5863

Genesis Cancer Center *Recruiting*
Hot Springs,  Arkansas,  71913
United States
Recruiting R.  Webb 501-624-7700

Siouxland Hematology-Oncology *Recruiting*
Sioux City,  Iowa,  51101-1733
United States
Recruiting Donald  Wender 712-252-0088

Gabrail Cancer Center - Canton Office *Recruiting*
Canton,  Ohio,  44718
United States
Recruiting Nashat  Gabrail 330-492-33345

Baystate Medical Center *Recruiting*
Springfield,  Massachusetts,  01199
United States
Recruiting Grace  Makari-Judson 413-794-5433

Orange Park Cancer Center *Recruiting*
Orange Park,  Florida,  32073
United States
Recruiting Linda  Sylvester 904-272-3139

Drexel University College of Medicine *Recruiting*
Philadelphia,  Pennsylvania,  19129
United States
Recruiting Pauline  Lerma 215-842-6980

Winthrop University Hospital *Recruiting*
Mineola,  New York,  11501
United States
Recruiting Harry  Staszewski 516-663-9500

Medical City Dallas Hospital *Recruiting*
Dallas,  Texas,  75230
United States
Recruiting Barry  Mirtsching 972-566-5588

Hotel Dieu de Montreal *Recruiting*
Montreal,  Quebec,  H2W 1T8
Canada
Recruiting Claude  Potvin 514-890-8000 ext. 25848

Santee Hematology Oncology *Recruiting*
Sumter,  South Carolina,  29150
United States
Recruiting Billy  Clowney 803-934-8833

Prince Edward Island Cancer Center at Queen Elizabeth Hospital *Recruiting*
Charlottetown,  Prince Edward Island,  C1A 8T5
Canada
Recruiting Dagny  Dryer 902-894-2027

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha *Recruiting*
Omaha,  Nebraska,  68114-4199
United States
Recruiting Robert  Langdon 402-354-8124

British Columbia Cancer Agency - Centre for the Southern Interior *Recruiting*
Kelowna,  British Columbia,  V1Y 5L3
Canada
Recruiting Marianne  Taylor 250-712-3996

Greenwich Hospital Association *Recruiting*
Greenwich,  Connecticut,  06830
United States
Recruiting Arthur  Rosenberg 203-863-3000

St. Joseph Medical Center *Recruiting*
Towson,  Maryland,  21204
United States
Recruiting Paul  Chang 410-337-4521

CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids,  Iowa,  52403-1206
United States
Recruiting Martin  Wiesenfeld 319-363-8303

Central Montgomery Medical Center *Recruiting*
Lansdale,  Pennsylvania,  19446-1200
United States
Recruiting Richard  Kosierowski 215-361-4747

University of Chicago Cancer Research Center *Recruiting*
Chicago,  Illinois,  60637-1470
United States
Recruiting Ann  Mauer 773-702-4138

Newfoundland Cancer Treatment and Research Foundation *Recruiting*
St. Johns,  Newfoundland and Labrador,  A1B 3V6
Canada
Recruiting Joy  McCarthy 709-777-7802

Cancer Associates of Northern Utah *Recruiting*
Ogden,  Utah,  84403
United States
Recruiting Vincent  Hansen 801-525-8837

Scarborough Hospital - General Site *Recruiting*
Scarborough,  Ontario,  M1P 2V5
Canada
Recruiting Henry  Krieger 416-438-2911

Algoma Reginal Cancer Program at Sault Area Hospital *Recruiting*
Sault Sainte Marie,  Ontario,  P6B 1Y5
Canada
Recruiting Paul  D. Walde 705-759-3434 ext. 4450

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

Hopital Charles Lemoyne *Recruiting*
Greenfield Park,  Quebec,  J4V 2H1
Canada
Recruiting Pierre  Desjardins 450-466-5065

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

Pottstown Memorial Regional Cancer Center *Recruiting*
Pottstown,  Pennsylvania,  19464
United States
Recruiting Wei  Song 610-327-7544

CancerCare Manitoba *Recruiting*
Winnipeg,  Manitoba,  R3E 0V9
Canada
Recruiting Debjani  Grenier 204-787-2127

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

Columbia Comprehensive Cancer Care Clinic *Recruiting*
Columbia,  Missouri,  65201
United States
Recruiting Ali  Khojasteh 573-893-6404

Royal Victoria Hospital, Barrie *Recruiting*
Barrie,  Ontario,  L4M 6M2
Canada
Recruiting Bryn  Pressnail 705-728-9802

Queens Medical Associates, PC *Recruiting*
Fresh Meadows,  New York,  11365
United States
Recruiting Barry  Kaplan 718-460-2300 ext. 614

Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina *Recruiting*
Greenville,  North Carolina,  27858-4354
United States
Recruiting Jennie  Crews 252-816-2560

Northern Virginia Oncology Group, P.C. *Recruiting*
Fairfax,  Virginia,  22031
United States
Recruiting Catherine  Broome 703-560-3205

Maine General Medical Center - Waterville *Recruiting*
Waterville,  Maine,  04901
United States
Recruiting Andrew  Hertler 207-872-1140

Northeastern Ontario Regional Cancer Centre - Sudbury *Recruiting*
Sudbury,  Ontario,  P3E 5J1
Canada
Recruiting Jonathan  Noble 705-522-6237 - ext. 2512

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

Nova Scotia Cancer Centre *Recruiting*
Halifax,  Nova Scotia,  B3H 1V7
Canada
Recruiting Daniel  Rayson 902-473-6002

Oncology/Hematology Care, Incorporated *Recruiting*
Cincinnati,  Ohio,  45236
United States
Recruiting David  Waterhouse 513-793-6052

Advanced Oncology Associates *Recruiting*
Armonk,  New York,  10504
United States
Recruiting Bernard  Bernhardt 914-632-5397

Cancer Care Ontario - Windsor Regional Cancer Centre *Recruiting*
Windsor,  Ontario,  N8W 2X3
Canada
Recruiting Caroline  Hamm 519-253-5253 ext. 58504

Staten Island University Hospital *Recruiting*
Staten Island,  New York,  10305
United States
Recruiting Terenig  Terjanian 718-226-6400

British Columbia Cancer Agency *Recruiting*
Vancouver,  British Columbia,  V5Z 4E6
Canada
Recruiting Karen  Gelmon 604-877-6000

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

Durham Regional Cancer Centre at Lakeridge Health Oshawa *Recruiting*
Oshawa,  Ontario,  L1G 2B9
Canada
Recruiting Jose  Chang 905-576-8711 ext. 4298

Hematology-Oncology Associates of Rockland, P.C. *Recruiting*
New City,  New York,  10956
United States
Recruiting Robert  March 845-362-1750

CCOP - Carle Cancer Center *Recruiting*
Urbana,  Illinois,  61801
United States
Recruiting Kendrith  Rowland 217-383-4083

Valley Hospital *Recruiting*
Ridgewood,  New Jersey,  07450-2736
United States
Recruiting Thomas  Rakowski 201-444-4526

CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines,  Iowa,  50309-1016
United States
Recruiting Roscoe  Morton 515-244-7586

Northwestern Ontario Regional Cancer Care *Recruiting*
Thunder Bay,  Ontario,  P7B 6V4
Canada
Recruiting Dimitrios  Vergidis 807-684-7200

Maisonneuve-Rosemont Hospital *Recruiting*
Montreal,  Quebec,  H1T 2M4
Canada
Recruiting Pierre  Dube 514-252-3400 ext. 4672

Saint John Regional Hospital *Recruiting*
Saint John,  New Brunswick,  E2L 4L2
Canada
Recruiting Margot  Burnell 506-648-6884

Redding Medical Center *Recruiting*
Redding,  California,  96001-0853
United States
Recruiting Ajay  Verma 530-244-5454

Associates in Oncology and Hematology *Recruiting*
Rockville,  Maryland,  20850
United States
Recruiting John  Wallmark 301-424-6231

Fraser Valley Cancer Centre at British Columbia Cancer Agency *Recruiting*
Surrey,  British Columbia,  V3V 1Z2
Canada
Recruiting Brian  Norris 604-930-4064

Northern Indiana Oncology Associates - South Bend *Recruiting*
South Bend,  Indiana,  46617
United States
Recruiting Rudolph  Navari 574-472-6400

CCOP - Ochsner *Recruiting*
New Orleans,  Louisiana,  70121
United States
Recruiting Carl  Kardinal 504-842-3910

Mayo Clinic Cancer Center *Recruiting*
Rochester,  Minnesota,  55905
United States
Recruiting Steven  Alberts 507-284-4918

Moncton Hospital *Recruiting*
Moncton,  New Brunswick,  E1C 6ZB
Canada
Recruiting Sheldon  Rubin 506-857-2881

Hotel Dieu Health Sciences Hospital - Niagara *Recruiting*
St. Catharines,  Ontario,  L2R 5K3
Canada
Recruiting Brian  Findlay 905-682-6451

Somerset Medical Center *Recruiting*
Somerville,  New Jersey,  08876
United States
Recruiting Kathleen  Toomey 908-685-2481

Associates in Oncology and Hematology *Recruiting*
Chattanooga,  Tennessee,  37404
United States
Recruiting Jitendra  Gandhi 423-622-2337

CCOP - Merit Care Hospital *Recruiting*
Fargo,  North Dakota,  58122
United States
Recruiting Preston  Steen 701-234-6161

Trillium Health Centre *Recruiting*
Mississauga,  Ontario,  L5B 1B8
Canada
Recruiting John  Gapski 905-270-3842

Arkansas Cancer Institute *Recruiting*
Pine Bluff,  Arkansas,  71603
United States
Recruiting Omar  Atiq 870-535-2800

Lone Star Oncology *Recruiting*
Austin,  Texas,  78759
United States
Recruiting John  Costanzi 512-343-2103

Centre Hospitalier de l'Universite de Montreal *Recruiting*
Montreal,  Quebec,  H2L 4M1
Canada
Recruiting Louise  Yelle 514-890-8000, ext. 25381

Grand River Regional Cancer Centre *Recruiting*
Kitchner,  Ontario,  N2G 1G3
Canada
Recruiting Nadia  Califaretti 519-749-4370

CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls,  South Dakota,  57104
United States
Recruiting Loren  Tschetter 605-328-8044

Little Rock Hematology-Oncology Associates *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Brad  Baltz 501-907-6444


Additional Information:
Study ID Numbers:
  CDR0000068520;  NCCTG-CAN-NCIC-MA21,P-UPJOHN-CAN-NCIC-MA21,JANSSEN-CAN-NCIC-MA21,CAN-NCIC-MA21,AMGEN-CAN-NCIC-MA21,BMS-CAN-NCIC-MA21
Study Start Date: 
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014222

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