Neoadjuvant Letrozole in Treating Postmenopausal Women With Estrogen-Receptor Positive and/or Progesterone-Receptor Positive Stage II, Stage IIIA, or Stage IIIB Breast Cancer
- Registration Number
- NCT00084396
- Lead Sponsor
- Washington University School of Medicine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 115
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Letrozole/Surgery conventional surgery - Letrozole/Surgery letrozole -
- Primary Outcome Measures
Name Time Method Predictive model for response as assessed by gene expression profiling
- Secondary Outcome Measures
Name Time Method Rate of improvement in surgical outcomes Response rate Changes in Ki67 proliferation rates Long-term outcomes Safety Mechanisms of resistance
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States