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
Overview
- Phase
- Phase 2
- Intervention
- letrozole
- Conditions
- Breast Cancer
- Sponsor
- Washington University School of Medicine
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Predictive model for response as assessed by gene expression profiling
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. Giving letrozole before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant letrozole works in treating postmenopausal women who are undergoing surgery for estrogen-receptor positive or progesterone-receptor positive stage II, stage IIIA, or stage IIIB breast cancer.
Detailed Description
OBJECTIVES: Primary * 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. Secondary * 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 drug. * 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 years. PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Letrozole/Surgery
Intervention: letrozole
Letrozole/Surgery
Intervention: conventional surgery
Outcomes
Primary Outcomes
Predictive model for response as assessed by gene expression profiling
Secondary Outcomes
- Rate of improvement in surgical outcomes
- Response rate
- Changes in Ki67 proliferation rates
- Long-term outcomes
- Safety
- Mechanisms of resistance