Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory … (NCT00066443) | Clinical Trial Compass
CompletedPhase 1/2
Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer
Canada93 participantsStarted 2003-11-03
Plain-language summary
RATIONALE: Drugs used in chemotherapy such as epirubicin and docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin and docetaxel with pegfilgrastim in treating women who have locally advanced or inflammatory breast cancer.
Who can participate
Age range16 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive adenocarcinoma of the breast, meeting any of the following criteria:
* T4, NX, M0
* Any T, N2-N3, M0
* Inflammatory breast cancer (redness over at least one-third of the breast), M0
* No evidence of metastatic disease by chest x-ray, abdominal ultrasound or CT scan and bone scan
* Diagnosed within the past 8 weeks
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 16 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic
* Bilirubin less than upper limit of normal (ULN)
* Must meet criteria for 1 of the following:
* ALT and AST no greater than 1.5 times ULN AND alkaline phosphatase no greater than 2.5 times ULN
* ALT and AST normal AND alkaline phosphatase no greater than 5 times ULN
Renal
* Creatinine no greater than 1.5 times ULN
Cardiovascular
* Resting LVEF normal by MUGA or echocardiogram
* No congestive heart failure
* No angina pectoris
* No myocardial infarction within the past year
* No uncontrolled hypertension
* No uncontrolled arrhythmias
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective non-hormonal contraception
* No other malignancy within the past 5 years except adequately treated nonmelanoma sk…