Pilot Study of Epirubicin and Cyclophosphamide Followed by Paclitaxel at 10-11 Days Interval for Women With Early Breast Carcinoma
OBJECTIVES:
- Determine the feasibility and safety of neoadjuvant or adjuvant epirubicin,
cyclophosphamide, and paclitaxel, in terms of the absence of any grade 3 or higher
toxicity (aside from alopecia), in women with high-risk stage I-III breast cancer.
OUTLINE: This is a pilot study.
- Neoadjuvant or adjuvant EC therapy: Patients receive epirubicin IV over 3-5 minutes and
cyclophosphamide IV (EC) on day 1 and filgrastim (G-CSF) subcutaneously on days 2-9 or
10. Treatment repeats every 10-11 days for 4 courses in the absence of disease
progression or unacceptable toxicity.
- Neoadjuvant or adjuvant paclitaxel therapy: After the completion of EC therapy,
patients receive paclitaxel IV over 3 hours on day 1. Patients also receive G-CSF as in
EC therapy. Treatment repeats every 10-11 days for 4 courses in the absence of disease
progression or unacceptable toxicity.
Patients who have not had prior surgery undergo definitive surgery after the completion of
chemotherapy. Patients also may receive adjuvant radiotherapy and/or hormonal therapy at the
discretion of the treating physician.
Patients are followed every 4 months for 3 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 11-38 patients will be accrued for this study within 1 year.
Interventional
Primary Purpose: Treatment
Monica N. Fornier, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
03-092
NCT00072319
August 2003
November 2006
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |