A Phase II Trial of Pre-Operative Taxol and Carboplatin in Women With Newly Diagnosed Locally Advanced Operable Breast Cancer
- 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
Patients refusing lumpectomy or mastectomy due to persistence of disease may undergo core
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 18 months.
Masking: Open Label, Primary Purpose: Treatment
Lisle M. Nabell, MD
University of Alabama at Birmingham
United States: Federal Government
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|