Breast Cancer Clinical Trial
Docetaxel, Carboplatin, and Pegfilgrastim in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer
Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving docetaxel and carboplatin together with pegfilgrastim before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together with pegfilgrastim works in treating patients who are undergoing surgery for stage II or stage III breast cancer.
Full Description
OBJECTIVES:
Primary
Determine the pathological complete response rate in patients with stage II or III breast cancer treated with neoadjuvant docetaxel, carboplatin, and pegfilgrastim.
Secondary
Determine the toxicity profile of this regimen in these patients.
Determine the rate of breast-conserving surgery in patients treated with this regimen.
Determine the clinical response rate in patients treated with this regimen.
Determine the feasibility of drug administration, in terms of the percent of planned dose actually administered per course, in patients treated with this regimen.
Determine the proportion of patients with negative pathologic lymph node status after treatment with this regimen.
Determine the proportion of patients with residual ductal carcinoma in situ after treatment with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
No more than 6 weeks after completion of chemotherapy, patients undergo definitive surgery.
After completion of study therapy, patients are followed every 6 months until disease progression and then annually for up to 5 years. Patients who do not complete all 4 courses of chemotherapy or do not undergo surgery are followed every 6 months for up to 5 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
Clinical stage II or III disease (including T2-4, N0-3)
No clinical or radiological evidence of distant metastases
Isolated supraclavicular lymph node involvement allowed
PATIENT CHARACTERISTICS:
Age
18 and over
Sex
Male or female
Menopausal status
Not specified
Performance status
ECOG 0-1
Life expectancy
At least 3 months
Hematopoietic
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10.0 g/dL
Hepatic
Bilirubin normal
Meets 1 of the following criteria:
AST or ALT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase normal
AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
AST or ALT normal AND alkaline phosphatase ≤ 5 times ULN
Renal
Creatinine clearance ≥ 30 mL/min
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 30 days after study treatment
No active unresolved infection
No history of severe hypersensitivity reaction to docetaxel, carboplatin, or any other drug formulated with polysorbate 80
No known hypersensitivity to E. coli-derived proteins, filgrastim (G-CSF), or pegfilgrastim
No peripheral neuropathy ≥ grade 2
No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Surgery
No prior surgical resection for invasive breast cancer
Other
No other prior therapy for invasive breast cancer
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There are 97 Locations for this study
Scottsdale Arizona, 85259, United States
Jacksonville Florida, 32224, United States
Aurora Illinois, 60507, United States
Bloomington Illinois, 61701, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Hopedale Illinois, 61747, United States
Joliet Illinois, 60435, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Moline Illinois, 61265, United States
Moline Illinois, 61265, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Spring Valley Illinois, 61362, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Beech Grove Indiana, 46107, United States
Michigan City Indiana, 46360, United States
Richmond Indiana, 47374, United States
Ames Iowa, 50010, United States
Bettendorf Iowa, 52722, United States
Cedar Rapids Iowa, 52403, United States
Des Moines Iowa, 50307, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67203, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Dearborn Michigan, 48123, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Grosse Pointe Woods Michigan, 48236, United States
Jackson Michigan, 49201, United States
Lansing Michigan, 48909, United States
Saginaw Michigan, 48601, United States
Warren Michigan, 48093, United States
Bemidji Minnesota, 56601, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Edina Minnesota, 55435, United States
Fergus Falls Minnesota, 56537, United States
Fridley Minnesota, 55432, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Robbinsdale Minnesota, 55422, United States
Rochester Minnesota, 55905, United States
Saint Cloud Minnesota, 56303, United States
Saint Louis Park Minnesota, 55416, United States
St. Cloud Minnesota, 56303, United States
St. Louis Park Minnesota, 55416, United States
St. Paul Minnesota, 55102, United States
Waconia Minnesota, 55387, United States
Woodbury Minnesota, 55125, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68122, United States
Omaha Nebraska, 68124, United States
Omaha Nebraska, 68131, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58502, United States
Fargo North Dakota, 58122, United States
Fargo North Dakota, 58122, United States
Dayton Ohio, 45405, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45428, United States
Dayton Ohio, 45429, United States
Findlay Ohio, 45840, United States
Kettering Ohio, 45429, United States
Middletown Ohio, 45044, United States
Troy Ohio, 45373, United States
Xenia Ohio, 45385, United States
Danville Pennsylvania, 17822, United States
State College Pennsylvania, 16801, United States
Wilkes-Barre Pennsylvania, 18711, United States
Rapid City South Dakota, 57701, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
La Crosse Wisconsin, 54601, United States
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