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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Correlation between change in apoptosis and proliferation with response after definitive surgery
Definitive surgery
No
Vered Stearns, MD
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
J0266 CDR0000346460
NCT00080626
July 2003
December 2015
Name | Location |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |