A Prevention Trial in Subjects at High Risk for Breast Cancer
Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
The primary objective of the proposed trial is to assess. The efficacy and the safety of a
daily administration of nimesulide or simvastatin to change the expression of a large set of
tissue and circulating surrogate endpoint biomarkers (SEBs) of breast carcinogenesis in women
at higher risk of developing a hormone non-responsive (ER neg) breast cancer. The primary
endpoint is the change in prevalence of atypical cells and cellular proliferation (Ki-67),
after 12 months of treatment.