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IBCSG 35-07 / BIG 1-07 : SOLE - Study Of Letrozole Extension
 
Trial Status:Pending
   
Treatment type:Hormone
   
Stage of Disease:Early
   
Intent of Treatment:Anticancer
   
 
Title:
 
A Phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years or prior adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive, node-positive early stage breast cancer.
 
 
Summary:
 
There is evidence confirming that hormonal treatment with drugs known as aromatase inhibitors (like letrozole) is effective in preventing breast cancer from returning.  However, the optimal duration or schedule for this treatment is not currently known.  4800 patients who have already completed 4-6 years of hormonal treatment will take part in SOLE, an international randomised clinical trial, and will receive hormonal treatment with the drug letrozole for a further 5 years. This trial will determine if introducing a treatment gap of 3 months every year, for 5 years has any benefit over continuous treatment for 5 years.
 
 
Coordinating Group:
 
Australia and New Zealand:
ANZ Breast Cancer Trials Group (ANZ BCTG)
International:
International Breast Cancer Study Group (IBCSG)
 
For more information:

Women who are interested in taking part in a clinical trial should discuss this with their doctor. In addition, please view links to other websites that provide information about clinical trial participation.
 
 
 

 

ANZ BCTG receives research infrastructure funding from the Cancer Institute NSW
and the Australian Government through Cancer Australia


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