The aim of this study is to assess the safety and efficacy of neoadjuvant hormone therapy with letrozole in postmenopausal women with estrogen- and/or progesterone-receptor positive primary breast cancer on tumour regression to permit breast conserving surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
2.5mg letrozole once-daily
Novartis Investigative Site
Bournemouth, United Kingdom
Novartis Investigative Site
Brighton, United Kingdom
Optimum length of treatment with letrozole (2.5 mg daily) preoperatively, on tumour measured by clinical examination and breast ultrasound
Time frame: 12 months
Reduction in tumour volume every 2 months throughout the study
Time frame: 12 months
Response rate in line with the Response Evaluation Criteria in Solid Tumors criteria
Time frame: 12 months
Long term (5-year) local recurrence rate
Time frame: 5 years
Safety and tolerability of the treatment prior to surgery
Time frame: 5 years
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Novartis Investigative Site
Bristol, United Kingdom
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Crewe, United Kingdom
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Dundee, United Kingdom
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East Sussex, United Kingdom
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Epping, United Kingdom
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Farnworth, United Kingdom
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