A Phase 2 Trial Of 4 Months Preoperative Letrozole 2.5 mg Daily For Postmenopausal Women With Estrogen Receptor Positive And/Or Progesterone Receptor Positive T2, T3, T4a-c, N0-2, M0 Breast Cancer- Novel Biomarkers for Aromatase Inhibitor Therapy
- Develop a predictive model of response (based on gene expression profiling) in
postmenopausal women with estrogen- and/or progesterone-receptor positive stage II,
IIIA, or IIIB breast cancer treated with neoadjuvant letrozole.
- Determine the response rate in patients treated with this drug.
- Determine changes in Ki67 proliferation rates in patients treated with this drug.
- Determine the rate of improvement in surgical outcomes in patients treated with this
- Determine the long-term outcomes in patients treated with this drug.
- Determine the safety of this drug in these patients.
- Determine mechanisms of resistance to this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive neoadjuvant oral letrozole once daily for 16 weeks in the absence of
disease progression. Patients then undergo breast surgery one day after the last dose of
letrozole. Patients with partial response after 16 weeks may continue to receive letrozole
for an additional 8 weeks before undergoing breast surgery.
Patients are followed within 4 weeks after definitive surgery and then annually for 10
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Predictive model for response as assessed by gene expression profiling
Matthew J. Ellis, MD, PhD, FRCP
Washington University Siteman Cancer Center
United States: Food and Drug Administration
|Washington University School of Medicine||Saint Louis, Missouri 63110|