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Spots Global Cancer Trial Database for Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer

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Trial Identification

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

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 ID: NCT00014222

Conditions

Breast Cancer

Study Description

Brief Summary: RATIONALE: 1. . To compare the effects on breast cancer of three different combinations of drugs which are commonly used to treat this disease. 2. . 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.

Detailed Description: OBJECTIVES: Primary * Compare the disease-free 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. Secondary * Compare the overall survival of patients treated with these regimens. * 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 and 8 and oral cyclophosphamide on days 1-14. Treatment repeats every 28 days for 6 courses. * Arm II: Patients receive epirubicin IV and cyclophosphamide IV on day 1 and filgrastim (G-CSF) subcutaneously (SC) on days 2-13. Patients with a hemoglobin \< 13.0 g/dL also receive epoetin alfa SC once weekly beginning within 1 week after the start of therapy and continuing as needed. 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. * Arm III: 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, day 1 of cycles 2, 3 4 and 6 (arm I), days 1 of cycles 3 and and day 1 of cycles 1 and 4 of paclitaxel (arm II), day 1 of cycles 2 and 3, day 1 of cycles 1 and 4 of paclitaxel, (arm III), 9 months, 12 months, and then annually thereafter until 5 years 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

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Sparks-Arkansas Oklahoma Cancer Treatment Centre, Fort Smith, Arkansas, United States

Hematology Oncology Services of Arkansas, Little Rock, Arkansas, United States

Scripps Cancer Center, La Jolla, California, United States

University of Colorado Cancer Centre, Aurora, Colorado, United States

Greenwich Hospital - Bendheim Cancer Center, Greenwich, Connecticut, United States

Sibley Memorial Hospital, Oncology Research, Washington, District of Columbia, United States

Comprehensive Cancer Care Centre at Boca Raton, Boca Raton, Florida, United States

University of Florida, Gainesville, Florida, United States

Florida Oncology Associates, Orange Park, Florida, United States

The University of Chicago Medical Center, Chicago, Illinois, United States

Therapy Associates, Inc., Hematology/Oncology, Evansville, Indiana, United States

Lexington Oncology Assts./Central Baptist Hospital, Lexington, Kentucky, United States

Consultants in Blood Disorders and Cancer, Louisville, Kentucky, United States

CHRISTUS Schumpert Medical Center - Hem/Onc Clinic, Shreveport, Louisiana, United States

Willis-Knighton Cancer Center, Shreveport, Louisiana, United States

Maine Center for Cancer Medicine and Blood Disorders, Scarborough, Maine, United States

Maine General Medical Center, Waterville, Maine, United States

Suburban Hospital Cancer Program, Bethesda, Maryland, United States

Associates in Oncology/Hematology, Rockville, Maryland, United States

Saint Joseph Medical Center, Cancer Care Program, Towson, Maryland, United States

Baystate Regional Cancer Program, Springfield, Massachusetts, United States

St. Luke's Cancer Care Centre, Duluth, Minnesota, United States

University of Minnesota Cancer Centre, Minneapolis, Minnesota, United States

Columbia-Capitol Comprehensive Care Clinics, Jefferson City, Missouri, United States

Saint Louis University Hospital, Saint Louis, Missouri, United States

Nebraska Methodist Hospital, Omaha, Nebraska, United States

Creighton University Cancer Centre, Omaha, Nebraska, United States

Advanced Oncology Associates, Armonk, New York, United States

Our Lady of Mercy Medical Center, Bronx, New York, United States

Queens Medical Associates, PC, Fresh Meadows, New York, United States

Winthrop University Hospital Onc/Hem, Mineola, New York, United States

Hematology Oncol. Associates Rockland, Nyack, New York, United States

University of Rochester, Rochester, New York, United States

Staten Island University Hospital, Staten Island, New York, United States

Duke University Medical Center, Durham, North Carolina, United States

ECU School of Medicine, Leo Jenkins Cancer Center, Greenville, North Carolina, United States

Oncology/Hematology Care, Inc., Cincinnati, Ohio, United States

Pottstown Memorial Regional Cancer Centre, Pottstown, Pennsylvania, United States

Santee Hematology Oncology, Sumter, South Carolina, United States

University Oncology and Hematology Associates, Chattanooga, Tennessee, United States

Lone Star Oncology Consultants, PA, Austin, Texas, United States

Center for Oncology Research and Treatment, Dallas, Texas, United States

Northern Utah Associates, Ogden, Utah, United States

Arlington-Fairfax Hematology Oncology P.C., Arlington, Virginia, United States

Tom Baker Cancer Centre, Calgary, Alberta, Canada

BCCA - Cancer Centre for the Southern Interior, Kelowna, British Columbia, Canada

BCCA - Fraser Valley Cancer Centre, Surrey, British Columbia, Canada

BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada

CancerCare Manitoba, Winnipeg, Manitoba, Canada

The Moncton Hospital, Moncton, New Brunswick, Canada

Atlantic Health Sciences Corporation, Saint John, New Brunswick, Canada

Dr. H. Bliss Murphy Cancer Centre, St. John's, Newfoundland and Labrador, Canada

QEII Health Sciences Center, Halifax, Nova Scotia, Canada

The Royal Victoria Hospital, Barrie, Ontario, Canada

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario, Canada

Grand River Regional Cancer Centre, Kitchener, Ontario, Canada

London Regional Cancer Program, London, Ontario, Canada

Lakeridge Health Oshawa, Oshawa, Ontario, Canada

Ottawa Health Research Institute - General Division, Ottawa, Ontario, Canada

Algoma District Cancer Program, Sault Ste. Marie, Ontario, Canada

The Scarborough Hospital, Scarborough, Ontario, Canada

Niagara Health System, St. Catharines, Ontario, Canada

Northeast Cancer Center Health Sciences, Sudbury, Ontario, Canada

Thunder Bay Regional Health Science Centre, Thunder Bay, Ontario, Canada

Odette Cancer Centre, Toronto, Ontario, Canada

St. Michael's Hospital, Toronto, Ontario, Canada

Mount Sinai Hospital, Toronto, Ontario, Canada

Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada

Trillium Health Centre - West Toronto, Toronto, Ontario, Canada

Windsor Regional Cancer Centre, Windsor, Ontario, Canada

PEI Cancer Treatment Centre,Queen Elizabeth Hospital, Charlottetown, Prince Edward Island, Canada

Hopital Charles LeMoyne, Greenfield Park, Quebec, Canada

Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada

CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada

CHUM - Hotel Dieu du Montreal, Montreal, Quebec, Canada

Allan Blair Cancer Centre, Regina, Saskatchewan, Canada

Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada

Contact Details

Name: Mark N. Levine, MD

Affiliation: Margaret and Charles Juravinski Cancer Centre

Role: STUDY_CHAIR

Name: Edith A. Perez, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Name: Kathy S. Albain, MD

Affiliation: Loyola University

Role: STUDY_CHAIR

Name: Margot Burnell

Affiliation: Atlantic Health Sciences Corporation, Saint John NB

Role: STUDY_CHAIR

Name: Hope Rugo

Affiliation: Cancer and Leukemia Group B

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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