neoadjuvant docetaxel in treating women with newly diagnosed breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed. purpose: this phase ii trial is studying how well neoadjuvant docetaxel works in treating women who are undergoing surgery for breast cancer.

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.

Eligibility criteria:
disease characteristics: * histologically confirmed infiltrating carcinoma of the breast * unresected clinical stage t1c, t2, t3, or t4 lesion, any n * newly diagnosed disease * diagnostic mammogram and an ultrasound of the affected breast within 3 months before study entry * mammogram of the contralateral breast within 6 months before study entry * clinically measurable disease * hormone receptor status: * immunohistochemical staining for estrogen and progesterone and her2/neu receptors must be obtained on initial diagnostic material patient characteristics: age * 18 and over sex * female menopausal status * not specified performance status * ecog 0-2 life expectancy * not specified hematopoietic * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 8 g/dl hepatic * bilirubin no greater than 1.5 times normal renal * creatinine no greater than 1.5 times normal other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no medical condition that would put the patient at unnecessary risk of potentially serious complications during study participation prior concurrent therapy: biologic therapy * not specified chemotherapy * no prior chemotherapy for current breast cancer endocrine therapy * at least 1 month since prior tamoxifen or raloxifene for breast cancer prevention * no prior endocrine therapy for current breast cancer radiotherapy * no prior radiotherapy for current breast cancer surgery * not specified

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer