Breast Cancer Clinical Trial

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

Summary

RATIONALE:

. To compare the effects on breast cancer of three different combinations of drugs which are commonly used to treat this disease.
. 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.

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Full 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.

View Eligibility Criteria

Eligibility 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 level II axillary node dissection with planned breast radiotherapy after completion of adjuvant chemotherapy regimen*
Patients with a positive sentinel node biopsy must undergo level II axillary node dissection or sufficient nodal sampling
If microscopic residual in situ or invasive disease is present at total or partial mastectomy margins, planned radiotherapy must also include a boost to the tumor bed
No residual tumor in the axilla after dissection

Axillary node positive

Negative nodes allowed if the tumor is ≥ 1 cm and 1 or more of the following criteria defining high-risk node-negative disease are met:

Histological grade III or,
Estrogen receptor negative or,
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 ≥ 3,000/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic:

Bilirubin ≤ 1.5 times upper limit of normal (ULN)

Renal:

Creatinine ≤ 1.5 times ULN

Cardiovascular:

LVEF ≥ 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 entry
No serious underlying medical illness or psychiatric or addictive disorder that would preclude study compliance
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

No concurrent pegfilgrastim or darbepoetin alfa (Arm II)

Allowed on arms 1 and 3 if medically necessary

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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

2104

Study ID:

NCT00014222

Recruitment Status:

Completed

Sponsor:

NCIC Clinical Trials Group

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There are 78 Locations for this study

See Locations Near You

Sparks-Arkansas Oklahoma Cancer Treatment Centre
Fort Smith Arkansas, 72901, United States
Hematology Oncology Services of Arkansas
Little Rock Arkansas, 72205, United States
Scripps Cancer Center
La Jolla California, 92037, United States
University of Colorado Cancer Centre
Aurora Colorado, 80010, United States
Greenwich Hospital - Bendheim Cancer Center
Greenwich Connecticut, 06830, United States
Sibley Memorial Hospital, Oncology Research
Washington District of Columbia, 20016, United States
Comprehensive Cancer Care Centre at Boca Raton
Boca Raton Florida, 33428, United States
University of Florida
Gainesville Florida, 32610, United States
Florida Oncology Associates
Orange Park Florida, 32073, United States
The University of Chicago Medical Center
Chicago Illinois, 60637, United States
Therapy Associates, Inc., Hematology/Oncology
Evansville Indiana, 47715, United States
Lexington Oncology Assts./Central Baptist Hospital
Lexington Kentucky, 40503, United States
Consultants in Blood Disorders and Cancer
Louisville Kentucky, 40207, United States
CHRISTUS Schumpert Medical Center - Hem/Onc Clinic
Shreveport Louisiana, 71101, United States
Willis-Knighton Cancer Center
Shreveport Louisiana, 71103, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough Maine, 04074, United States
Maine General Medical Center
Waterville Maine, 04901, United States
Suburban Hospital Cancer Program
Bethesda Maryland, 20817, United States
Associates in Oncology/Hematology
Rockville Maryland, 20850, United States
Saint Joseph Medical Center, Cancer Care Program
Towson Maryland, 21204, United States
Baystate Regional Cancer Program
Springfield Massachusetts, 01107, United States
St. Luke's Cancer Care Centre
Duluth Minnesota, 55802, United States
University of Minnesota Cancer Centre
Minneapolis Minnesota, 55455, United States
Columbia-Capitol Comprehensive Care Clinics
Jefferson City Missouri, 65109, United States
Saint Louis University Hospital
Saint Louis Missouri, 63110, United States
Nebraska Methodist Hospital
Omaha Nebraska, 68114, United States
Creighton University Cancer Centre
Omaha Nebraska, 68131, United States
Advanced Oncology Associates
Armonk New York, 10504, United States
Our Lady of Mercy Medical Center
Bronx New York, 10466, United States
Queens Medical Associates, PC
Fresh Meadows New York, 11366, United States
Winthrop University Hospital Onc/Hem
Mineola New York, 11501, United States
Hematology Oncol. Associates Rockland
Nyack New York, 10960, United States
University of Rochester
Rochester New York, 14642, United States
Staten Island University Hospital
Staten Island New York, 10305, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
ECU School of Medicine, Leo Jenkins Cancer Center
Greenville North Carolina, 27858, United States
Oncology/Hematology Care, Inc.
Cincinnati Ohio, 45242, United States
Pottstown Memorial Regional Cancer Centre
Pottstown Pennsylvania, 19464, United States
Santee Hematology Oncology
Sumter South Carolina, 29150, United States
University Oncology and Hematology Associates
Chattanooga Tennessee, 37404, United States
Lone Star Oncology Consultants, PA
Austin Texas, 78759, United States
Center for Oncology Research and Treatment
Dallas Texas, 75230, United States
Northern Utah Associates
Ogden Utah, 84403, United States
Arlington-Fairfax Hematology Oncology P.C.
Arlington Virginia, 22205, United States
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
BCCA - Cancer Centre for the Southern Interior
Kelowna British Columbia, V1Y 5, Canada
BCCA - Fraser Valley Cancer Centre
Surrey British Columbia, V3V 1, Canada
BCCA - Vancouver Cancer Centre
Vancouver British Columbia, V5Z 4, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
The Moncton Hospital
Moncton New Brunswick, E1C 6, Canada
Atlantic Health Sciences Corporation
Saint John New Brunswick, E2L 4, Canada
Dr. H. Bliss Murphy Cancer Centre
St. John's Newfoundland and Labrador, AIB 3, Canada
QEII Health Sciences Center
Halifax Nova Scotia, B3H 1, Canada
The Royal Victoria Hospital
Barrie Ontario, L4M 6, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton Ontario, L8V 5, Canada
Cancer Centre of Southeastern Ontario at Kingston
Kingston Ontario, K7L 5, Canada
Grand River Regional Cancer Centre
Kitchener Ontario, N2G 1, Canada
London Regional Cancer Program
London Ontario, N6A 4, Canada
Lakeridge Health Oshawa
Oshawa Ontario, L1G 2, Canada
Ottawa Health Research Institute - General Division
Ottawa Ontario, K1H 8, Canada
Algoma District Cancer Program
Sault Ste. Marie Ontario, P6B 0, Canada
The Scarborough Hospital
Scarborough Ontario, M1P 2, Canada
Niagara Health System
St. Catharines Ontario, L2R 7, Canada
Northeast Cancer Center Health Sciences
Sudbury Ontario, P3E 5, Canada
Thunder Bay Regional Health Science Centre
Thunder Bay Ontario, P7B 6, Canada
Odette Cancer Centre
Toronto Ontario, M4N 3, Canada
St. Michael's Hospital
Toronto Ontario, M5B 1, Canada
Mount Sinai Hospital
Toronto Ontario, M5G 1, Canada
Univ. Health Network-Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Trillium Health Centre - West Toronto
Toronto Ontario, M9C 1, Canada
Windsor Regional Cancer Centre
Windsor Ontario, N8W 2, Canada
PEI Cancer Treatment Centre,Queen Elizabeth Hospital
Charlottetown Prince Edward Island, C1A 8, Canada
Hopital Charles LeMoyne
Greenfield Park Quebec, J4V 2, Canada
Hopital Maisonneuve-Rosemont
Montreal Quebec, H1T 2, Canada
CHUM - Hopital Notre-Dame
Montreal Quebec, H2L 4, Canada
CHUM - Hotel Dieu du Montreal
Montreal Quebec, H2W 1, Canada
Allan Blair Cancer Centre
Regina Saskatchewan, S4T 7, Canada
Saskatoon Cancer Centre
Saskatoon Saskatchewan, S7N 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

2104

Study ID:

NCT00014222

Recruitment Status:

Completed

Sponsor:


NCIC Clinical Trials Group

How clear is this clinincal trial information?

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