Trial Information

A Pilot Study Assessing Patterns of Response or Resistance to Preoperative Dose Dense Docetaxel in Women With Newly Diagnosed 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.