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MA17R Details
Status: Closed 
Activation Date: 2004OCT14
Closing Date: 2009MAY08
Phase: III 

Description: A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed with Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen (Including Those in the MA.17 Study) 

Eligibility: Women completing around five years of aromatase inhibitor therapy, either as initial therapy or after tamoxifen, including those who received letrozole within the MA.17 study, are eligible for randomization to a further five years of letrozole or placebo. Eligible subjects must be free of recurrent breast cancer and have completed the five years of aromatase inhibitor therapy no more than 2 years prior to randomization. BMD measured by DEXA should be done within 4 weeks prior to randomization if not done within the previous 12 months, but the results do not affect eligibility. 

Objective: To compare the disease-free survival of subjects who receive 5 years of letrozole or placebo after having received around 5 years (4.5 - 6) of aromatase inhibitor therapy (letrozole, anastrozole, or exemestane) including those who received 5 years of adjuvant letrozole as part of the MA.17 trial. To evaluate the effect on overall (all cause specific) mortality. To evaluate the incidence of contralateral breast cancer. To evaluate the long term clinicial and laboratory safety of aromatase inhibitor therapy which includes 5 years of letrozole therapy. To evaluate overall quality of life (SF-36) and menopausal specific QOL (Menqol). To test the hypothesis that common genetic polymorphisms for genes encoding proteins involved in pharmacokinetic and/or pharmacodynamic pathways for the aromatase inhibitor letrozole contribute to individual variation in toxicity and efficacy of letrozole therapy. 

Participation: Open to centres in participating cooperative groups. 

Lay Description: The purpose of this follow-up study to the original MA.17 trial is to see if taking an aromatase inhibitor for more than five years is better than taking it for just 5 years. At the present time 5 years of treatment with an aromatase inhibitor is considered the standard of care. It is not known if additional treatment will add further benefit. Also long term side effects may occur while on an aromatase inhibitor and these could outweigh any benefits of continuing treatment. To find out if aromatase inhibitor therapy should be continued beyond five years, half of the patients in the study, after completing the initial five years of aromatase inhibitor therapy, will receive an additional five years of letrozole and the other half will receive placebo (a preparation with no active substance of medicinal value). Treatment with letrozole or placebo will begin as soon as possible and no later than two years after completing the first five years of aromatase inhibitor therapy. 

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