Finding studies
Finding studies
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Lead
University of Alabama at Birmingham
With
OBJECTIVES: * Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin. * Evaluate specific biomarkers for prognostic value and as markers for response/resistance in patients treated with this regimen. * Determine the tolerability and toxicity of this regimen in these patients. OUTLINE: This is an open-label study. Patients with non-palpable lymph nodes undergo sentinel lymph node biopsy within 4 weeks before beginning neoadjuvant chemotherapy. All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo lumpectomy or modified radical mastectomy. Patients with a positive sentinel lymph node biopsy or palpable axillary adenopathy undergo axillary lymph node dissection. All patients undergoing lumpectomy or mastectomy with high-risk disease also undergo radiotherapy. Patients refusing lumpectomy or mastectomy due to persistence of disease may undergo core needle biopsy. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 18 months.
Age
18–120
Sex
FEMALE
Healthy volunteers
Not accepted