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.
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- 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.
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Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 115
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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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