Pilot Study of Neoadjuvant Dose Dense Docetaxel With Correlative Molecular Studies in Stage II/III Breast Cancer
- Pathologic complete response rate (pCR) of dose dense docetaxel in the neoadjuvant
- Safety and toxic effects of this regimen in these patients.
- Tumor response rate (as measured by ultrasound) in patients treated with this regimen.
- Determine whether early changes in markers of cell cycle position, proliferation, or
apoptosis correlate with pathologic complete response rate in these patients.
- Determine whether the molecular profile that predicts for chemoresponsiveness also
predicts for response to radiotherapy (as measured by local recurrence) in these
- Determine whether tumors that demonstrate the greatest degree of change in protein
expression patterns from pre- to post-docetaxel treatment will also be those that are
most sensitive to chemotherapy (as measured by pathologic response rate) in these
OUTLINE: This is a nonrandomized, open-label, pilot study.
- Tissue Collection: Patients undergo tumor core biopsy (6-8 cores) and blood collection
prior to initiating neoadjuvant docetaxel.
- Neoadjuvant docetaxel with hematopoietic support: Patients receive docetaxel IV over 1
hour on day 1. Patients also receive pegfilgrastim subcutaneously (SC) on day 1 or 2 of
each course OR filgrastim (G-CSF) or sargramostim (GM-CSF) SC daily beginning between
day 2-4 of each course and continuing until blood counts recover. Treatment repeats
every 14 days for up to 4 courses in the absence of disease progression or unacceptable
- Surgery: Within 4-6 weeks after completion of neoadjuvant docetaxel, patients undergo
Patients undergo tumor biopsy and blood collection periodically for pharmacokinetic,
genetic, and molecular biomarker correlative studies. Samples are examined for changes in
p21 protein expression (and/or p21 phosphorylation) and the protein expression profile.
After completion of study treatment, patients are followed at least every 6 months for 3
years and then annually thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number Participants to Achieve Pathologic Complete Response
whether or not patient has pathologic complete response (pCR) to dose dense docetaxel in the neoadjuvant setting (pCR = no residual viable tumor on histologic analysis)
A. Bapsi Chakravarthy, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC BRE 0368
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Meharry Medical College||Nashville, Tennessee 37208-3599|