Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
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.
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study Assessing Patterns of Response or Resistance to Preoperative Dose Dense Docetaxel in Women With Newly Diagnosed Breast Cancer|
- Correlation between change in apoptosis and proliferation with response after definitive surgery [ Time Frame: Definitive surgery ] [ Designated as safety issue: No ]
- Correlation between change in fludeoxyglucose F 18 positron emission tomography uptake with response after definitive surgery [ Time Frame: Definitive surgery ] [ Designated as safety issue: No ]
|Study Start Date:||July 2003|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
Neoadjuvant therapy with docetaxel (IV, 100 mg/m2, every 14 days with growth factor support with pegfilgrastim) for a total of 4 cycles prior to conventional surgery for breast cancer
6 mg injection on day 1 of each cycle
Other Name: NeulastaDrug: docetaxel
100 mg per meter-squared, every 14 days for 4 cycles
Other Name: TaxotereProcedure: conventional surgery
lumpectomy or mastectomy at end of treatment
Other Name: definitive surgeryProcedure: neoadjuvant therapy
treatment prior to definitive breast surgery
- 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.
- 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.
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Principal Investigator:||Vered Stearns, MD||Sidney Kimmel Comprehensive Cancer Center|