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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 78 Locations for this study
Fort Smith Arkansas, 72901, United States
Little Rock Arkansas, 72205, United States
La Jolla California, 92037, United States
Aurora Colorado, 80010, United States
Greenwich Connecticut, 06830, United States
Washington District of Columbia, 20016, United States
Boca Raton Florida, 33428, United States
Gainesville Florida, 32610, United States
Orange Park Florida, 32073, United States
Chicago Illinois, 60637, United States
Evansville Indiana, 47715, United States
Lexington Kentucky, 40503, United States
Louisville Kentucky, 40207, United States
Shreveport Louisiana, 71101, United States
Shreveport Louisiana, 71103, United States
Scarborough Maine, 04074, United States
Waterville Maine, 04901, United States
Bethesda Maryland, 20817, United States
Rockville Maryland, 20850, United States
Towson Maryland, 21204, United States
Springfield Massachusetts, 01107, United States
Duluth Minnesota, 55802, United States
Minneapolis Minnesota, 55455, United States
Jefferson City Missouri, 65109, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68114, United States
Omaha Nebraska, 68131, United States
Armonk New York, 10504, United States
Bronx New York, 10466, United States
Fresh Meadows New York, 11366, United States
Mineola New York, 11501, United States
Nyack New York, 10960, United States
Rochester New York, 14642, United States
Staten Island New York, 10305, United States
Durham North Carolina, 27710, United States
Greenville North Carolina, 27858, United States
Cincinnati Ohio, 45242, United States
Pottstown Pennsylvania, 19464, United States
Sumter South Carolina, 29150, United States
Chattanooga Tennessee, 37404, United States
Austin Texas, 78759, United States
Dallas Texas, 75230, United States
Ogden Utah, 84403, United States
Arlington Virginia, 22205, United States
Calgary Alberta, T2N 4, Canada
Kelowna British Columbia, V1Y 5, Canada
Surrey British Columbia, V3V 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Winnipeg Manitoba, R3E 0, Canada
Moncton New Brunswick, E1C 6, Canada
Saint John New Brunswick, E2L 4, Canada
St. John's Newfoundland and Labrador, AIB 3, Canada
Halifax Nova Scotia, B3H 1, Canada
Barrie Ontario, L4M 6, Canada
Hamilton Ontario, L8V 5, Canada
Kingston Ontario, K7L 5, Canada
Kitchener Ontario, N2G 1, Canada
London Ontario, N6A 4, Canada
Oshawa Ontario, L1G 2, Canada
Ottawa Ontario, K1H 8, Canada
Sault Ste. Marie Ontario, P6B 0, Canada
Scarborough Ontario, M1P 2, Canada
St. Catharines Ontario, L2R 7, Canada
Sudbury Ontario, P3E 5, Canada
Thunder Bay Ontario, P7B 6, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5B 1, Canada
Toronto Ontario, M5G 1, Canada
Toronto Ontario, M5G 2, Canada
Toronto Ontario, M9C 1, Canada
Windsor Ontario, N8W 2, Canada
Charlottetown Prince Edward Island, C1A 8, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H2L 4, Canada
Montreal Quebec, H2W 1, Canada
Regina Saskatchewan, S4T 7, Canada
Saskatoon Saskatchewan, S7N 4, Canada
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.