Neoadjuvant Letrozole in Treating Postmenopausal Women With Estrogen-Receptor Positive and/or Progesterone-Receptor Positive Stage II, Stage IIIA, or Stage IIIB Breast Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Predictive model for response as assessed by gene expression profiling [ Designated as safety issue: No ]
- Response rate [ Designated as safety issue: No ]
- Changes in Ki67 proliferation rates [ Designated as safety issue: No ]
- Rate of improvement in surgical outcomes [ Designated as safety issue: No ]
- Long-term outcomes [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Mechanisms of resistance [ Designated as safety issue: No ]
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||March 2017|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
|Experimental: Letrozole/Surgery||Drug: letrozole Procedure: conventional surgery|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084396
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Michael Naughton, M.D.||Washington University School of Medicine|