Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
With
OBJECTIVES: Primary * Correlate baseline and change in apoptosis and proliferation with clinical and pathological response to neoadjuvant docetaxel followed by surgery in women with newly diagnosed breast cancer. Secondary * Correlate baseline and change in fludeoxyglucose F 18 positron emission tomography uptake with clinical and pathological response in patients treated with this regimen. * Correlate baseline and change in gene expression profiles with clinical and pathological response in patients treated with this regimen. * Correlate baseline and change in tumor and serum proteomic patterns with clinical and pathological response in patients treated with this regimen. OUTLINE: This is a pilot study. * Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on day 1 and pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. * Surgery: Within 2-4 weeks after the completion of 4 courses of docetaxel, patients undergo breast-conserving surgery or a mastectomy at the discretion of the treating surgeon. Patients may receive additional chemotherapy prior to surgery at the discretion of the treating physician. * Adjuvant chemotherapy: Patients receive adjuvant chemotherapy at the discretion of the treating physician. * Radiotherapy: Patients undergo radiotherapy after the completion of all chemotherapy at the discretion of the treating physician. * Hormonal therapy: Patients with estrogen- and/or progesterone-positive tumors receive hormonal therapy after the completion of chemotherapy and all local therapies at the discretion of the treating physician. Patients are followed every 6 months. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
