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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Collaborators: |
North Central Cancer Treatment Group Southwest Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00014222 |
Purpose
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: Randomized phase 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: epoetin alfa Biological: filgrastim Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: fluorouracil Drug: paclitaxel Procedure: adjuvant therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Phase III Adjuvant Trial Of Sequenced EC + Filgrastim + Epoetin Alfa Followed By Paclitaxel Versus Sequenced AC Followed By Paclitaxel Versus CEF As Therapy For Premenopausal Women And Early Postmenopausal Women Who Have Had Potentially Curative Surgery For Node Positive Or High Risk Node Negative Breast Cancer |
| Study Start Date: | December 2000 |
OBJECTIVES:
Primary
Secondary
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.
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.
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 2,100 patients (700 per treatment arm) will be accrued for this study within 4 years.
Eligibility| Ages Eligible for Study: | up to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast that is potentially curable
Previously treated with one of the following:
Axillary node positive
Negative nodes allowed if the tumor is ≥ 1 cm and 1 of the following criteria defining high-risk node-negative disease are met:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No other malignancy except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No concurrent pegfilgrastim or darbepoetin alfa (Arm II)
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| CCOP - Mayo Clinic Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, Arkansas | |
| Arkansas Cancer Institute | |
| Pine Bluff, Arkansas, United States, 71603 | |
| Genesis Cancer Center | |
| Hot Springs, Arkansas, United States, 71913 | |
| Little Rock Hematology-Oncology Associates | |
| Little Rock, Arkansas, United States, 72205 | |
| Sparks Regional Medical Center | |
| Fort Smith, Arkansas, United States, 72901-5128 | |
| United States, California | |
| Scripps Cancer Center at Scripps Clinic | |
| La Jolla, California, United States, 92037 | |
| Shasta Regional Medical Center | |
| Redding, California, United States, 96001-0853 | |
| United States, Colorado | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80010 | |
| United States, Connecticut | |
| Greenwich Hospital Association | |
| Greenwich, Connecticut, United States, 06830 | |
| United States, District of Columbia | |
| Sibley Memorial Hospital | |
| Washington, District of Columbia, United States, 20016 | |
| United States, Florida | |
| Lynn Regional Cancer Center of Boca Raton Community Hospital | |
| Boca Raton, Florida, United States, 33466 | |
| University of Florida Shands Cancer Center | |
| Gainesville, Florida, United States, 32610-0232 | |
| Orange Park Cancer Center | |
| Orange Park, Florida, United States, 32073 | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| United States, Hawaii | |
| MBCCOP - Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153-5589 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| La Grange Oncology Associates | |
| La Grange, Illinois, United States, 60525 | |
| Swedish-American Regional Cancer Center | |
| Rockford, Illinois, United States, 61104-2315 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Indiana | |
| Evansville Cancer Center | |
| Evansville, Indiana, United States, 47715 | |
| Northern Indiana Oncology Associates - South Bend | |
| South Bend, Indiana, United States, 46617 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Siouxland Hematology-Oncology Associates | |
| Sioux City, Iowa, United States, 51101-1733 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Kentucky | |
| Central Baptist Hospital | |
| Lexington, Kentucky, United States, 40503 | |
| Consultants in Blood Disorders and Cancer | |
| Louisville, Kentucky, United States, 40207 | |
| Graves-Gilbert Clinic | |
| Bowling Green, Kentucky, United States, 42102-9007 | |
| United States, Louisiana | |
| Cancer Treatment Center at Christus Schumpert St. Mary Place | |
| Shreveport, Louisiana, United States, 71101 | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| Willis - Knighton South Center for Women's Health | |
| Shreveport, Louisiana, United States, 71118 | |
| United States, Maine | |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | |
| Scarborough, Maine, United States, 04074 | |
| Maine General Medical Center - Waterville | |
| Waterville, Maine, United States, 04901 | |
| United States, Maryland | |
| Associates in Oncology and Hematology | |
| Rockville, Maryland, United States, 20850 | |
| St. Joseph Medical Center | |
| Towson, Maryland, United States, 21204 | |
| Suburban Hospital Cancer Program | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Massachusetts | |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | |
| Springfield, Massachusetts, United States, 01107 | |
| United States, Minnesota | |
| Cancer Care Center at St. Luke's Hospital | |
| Duluth, Minnesota, United States, 55805 | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Columbia Comprehensive Cancer Care Clinic | |
| Columbia, Missouri, United States, 65201 | |
| Saint Louis University Cancer Center | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Cancer Center at Creighton University Medical Center | |
| Omaha, Nebraska, United States, 68131-2197 | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68106 | |
| Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | |
| Omaha, Nebraska, United States, 68114-4199 | |
| United States, New Jersey | |
| Somerset Medical Center | |
| Somerville, New Jersey, United States, 08876 | |
| Valley Hospital - Ridgewood | |
| Ridgewood, New Jersey, United States, 07450-2736 | |
| United States, New York | |
| Advanced Oncology Associates | |
| Armonk, New York, United States, 10504 | |
| Hematology-Oncology Associates of Rockland, P.C. | |
| New City, New York, United States, 10956 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Nalitt Cancer Institute at Staten Island University Hospital | |
| Staten Island, New York, United States, 10305 | |
| Queens Medical Associates, PC | |
| Fresh Meadows, New York, United States, 11365 | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital | |
| Greenville, North Carolina, United States, 27858-4354 | |
| United States, North Dakota | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| Medcenter One Health System | |
| Bismarck, North Dakota, United States, 58501-5505 | |
| United States, Ohio | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| CCOP - Toledo Community Hospital | |
| Toledo, Ohio, United States, 43623-3456 | |
| Gabrail Cancer Center - Canton Office | |
| Canton, Ohio, United States, 44718 | |
| Lawrence M. Stallings Medical Practice | |
| Wooster, Ohio, United States, 44691 | |
| Oncology Hematology Care, Incorporated - Mt. Auburn/Taft Road | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Pennsylvania | |
| Cancer Center of Drexel University College of Medicine | |
| Philadelphia, Pennsylvania, United States, 19129 | |
| CCOP - Geisinger Clinic and Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| Central Montgomery Medical Center | |
| Lansdale, Pennsylvania, United States, 19446-1200 | |
| Pottstown Memorial Regional Cancer Center | |
| Pottstown, Pennsylvania, United States, 19464 | |
| United States, South Carolina | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Santee Hematology Oncology | |
| Sumter, South Carolina, United States, 29150 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57104 | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57709 | |
| United States, Tennessee | |
| Associates in Oncology and Hematology | |
| Chattanooga, Tennessee, United States, 37404 | |
| United States, Texas | |
| Lone Star Oncology - Austin | |
| Austin, Texas, United States, 78759 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| United States, Utah | |
| Cancer Associates of Northern Utah | |
| Ogden, Utah, United States, 84403 | |
| United States, Virginia | |
| Arlington-Fairfax Hematology/Oncology, PC | |
| Arlington, Virginia, United States, 22205 | |
| Northern Virginia Oncology Group, P.C. | |
| Fairfax, Virginia, United States, 22031 | |
| United States, Wyoming | |
| Ivinson Memorial Hospital | |
| Laramie, Wyoming, United States, 82070 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency - Centre for the Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| British Columbia Cancer Agency - Vancouver Cancer Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Fraser Valley Cancer Centre at Surrey Memorial Hospital | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| Nanaimo Cancer Clinic at Nanaimo Regional General Hospital | |
| Nanaimo, British Columbia, Canada, V9S 2B7 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, New Brunswick | |
| Moncton Hospital | |
| Moncton, New Brunswick, Canada, E1C 6ZB | |
| Saint John Regional Hospital | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Newfoundland and Labrador | |
| Newfoundland Cancer Treatment and Research Foundation | |
| St. Johns, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Algoma Regional Cancer Program at Sault Area Hospital | |
| Sault Sainte Marie, Ontario, Canada, P6A 2C4 | |
| Cancer Care Ontario - Windsor Regional Cancer Centre | |
| Windsor, Ontario, Canada, N8W 2X3 | |
| Cancer Centre of Southeastern Ontario | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Durham Regional Cancer Centre at Lakeridge Health Oshawa | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| Grand River Regional Cancer Centre at Grand River Hospital | |
| Kitchner, Ontario, Canada, N2G 1G3 | |
| Hotel Dieu Health Sciences Hospital - Niagara | |
| St. Catharines, Ontario, Canada, L2R 5K3 | |
| Regional Cancer Care at Thunder Bay Regional Health Sciences Centre | |
| Thunder Bay, Ontario, Canada, P7B 6V4 | |
| Margaret and Charles Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Mount Sinai Hospital - Toronto | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Northeastern Ontario Regional Cancer Centre | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Peterborough Oncology Clinic | |
| Peterborough, Ontario, Canada, K9H 7B6 | |
| London Regional Cancer Program at London Health Sciences Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Royal Victoria Hospital of Barrie | |
| Barrie, Ontario, Canada, L4M 6M2 | |
| Scarborough Hospital - General Site | |
| Scarborough, Ontario, Canada, M1P 2V5 | |
| St. Joseph's Health Centre - Toronto | |
| Toronto, Ontario, Canada, M6R 1B5 | |
| St. Michael's Hospital - Toronto | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Trillium Health Centre - Mississauga | |
| Mississauga, Ontario, Canada, L5B 1B8 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Canada, Prince Edward Island | |
| Prince Edward Island Cancer Centre at Queen Elizabeth Hospital | |
| Charlottetown, Prince Edward Island, Canada, C1A 8T5 | |
| Canada, Quebec | |
| Centre Hospitalier de l'Universite de Montreal | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Hopital Charles Lemoyne | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| Hotel Dieu de Montreal | |
| Montreal, Quebec, Canada, H2W 1T8 | |
| Maisonneuve-Rosemont Hospital | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre at Pasqua Hospital | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Saskatoon Cancer Centre | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Study Chair: | Mark N. Levine, MD | Margaret and Charles Juravinski Cancer Centre |
| Study Chair: | Edith A. Perez, MD | Mayo Clinic |
| Investigator: | Kathy S. Albain, MD | Loyola University |
More Information
| Study ID Numbers: | CDR0000068520, CAN-NCIC-MA21, AMGEN-CAN-NCIC-MA21, NCCTG-CAN-NCIC-MA21, BMS-CAN-NCIC-MA21, JANSSEN-ORTHO-CAN-NCIC-MA21, PFIZER-CAN-NCIC-MA21, SWOG-CAN-NCIC-MA21 |
| Study First Received: | April 10, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00014222 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
|
Antimetabolites Epoetin Alfa Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neoplasms by Site Therapeutic Uses Alkylating Agents Breast Diseases Skin Diseases |
Hematinics Mitosis Modulators Adjuvants, Immunologic Breast Neoplasms Antimitotic Agents Epirubicin Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neoplasms Paclitaxel Fluorouracil Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating |