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This study examines epirubicin hydrochloride chemotherapy in women undergoing surgery for stage I, II, or III breast cancer. It enrolled female patients with histologically confirmed, resectable breast cancer. The research was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive breast cancer
* Stage I, II, or III disease (T1, T2, or T4; N0-2; M0)
* Resectable disease
* Unidimensionally measurable disease
* Primary tumor ≥ 2 cm
* No known distant metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Sex
* Female
Menopausal status
* Not specified
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 3,500/mm\^3
* Hemoglobin ≥ 8 g/dL
* Platelet count ≥ 100,000/mm\^3
* No known untreated bleeding diathesis
Hepatic
* AST ≤ 2 times upper limits of normal
* Bilirubin ≤ 1.5 mg/dL
Renal
* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* LVEF ≥ 50% on echocardiogram, MUGA, or cardiac catheterization
Other
* Not pregnant or breastfeeding
* Fertile patients must use effective contraception
* Negative pregnancy test
* No concurrent illness that would preclude study treatment
* No known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim (G-CSF), or any other component of these products
PRIOR CONCURRENT THERAPY: Not specified