A Pilot Study of Neoadjuvant Paclitaxel and Concurrent Radiation With Correlative Molecular Studies in Stage II/III Breast Cancer
- Evaluate the efficacy of paclitaxel and concurrent radiotherapy (as measured by
pathologic response rates) in patients with stage II or III breast cancer.
- Evaluate the toxicities of this treatment regimen.
- Correlate paclitaxel-induced tumor response with local recurrence-free survival,
distant disease-free survival, and overall survival.
- Evaluate protein expression profiles by mass spectrometry in biopsy material and blood
specimens collected before and after treatment with paclitaxel.
- Neoadjuvant chemotherapy: Patients receive paclitaxel IV over 3 hours on day 1.
Treatment repeats every 21 days for 3 courses in the absence of disease progression or
- Chemoradiotherapy: Beginning 3-4 weeks after completion of neoadjuvant chemotherapy,
patients receive paclitaxel IV over 1 hour twice weekly and undergo radiotherapy once
daily, 5 days a week, for 6½ weeks.
- Surgery: At 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical
resection (e.g., modified radical mastectomy or lumpectomy and axillary node
- Adjuvant chemotherapy: Beginning 4-6 weeks after surgery, patients receive doxorubicin
hydrochloride IV over 20 minutes and cyclophosphamide IV over 1 hour on day 1.
Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or
- Hormonal therapy: After completion of adjuvant chemotherapy, patients with estrogen
receptor- and/or progesterone receptor-positive tumor receive hormonal therapy at the
discretion of the treating physician.
Patients undergo blood and tissue sample collection periodically to analyze changes in cell
cycle by flow cytometry; antibody assays; kinase assays for cyclin B1/CDC2; genetic assays
for p53, p21, and other molecular markers; and protein expression assays by mass
After completion of study therapy, patients are followed periodically.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic Complete Response Rate
A. Bapsi Chakravarthy, MD
Vanderbilt-Ingram Cancer Center
United States: Federal Government
VCC BRE 9936
|Williamson Medical Center||Franklin, Tennessee 37067|
|Meharry Medical College||Nashville, Tennessee 37208-3599|
|Boston Baskin Cancer Center||Memphis, Tennessee 38104|
|Vanderbilt-Ingram Cancer Cetner||Nashville, Tennessee|
|Jackson-Madison Hospital||Jackson, Tennessee 38301|
|Methodist Lebonheur Healthcare||Memphis, Tennessee 38104|