A Prevention Trial in Subjects at High Risk for Breast Cancer

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.

Timeline

Start

2005-04

Primary completion

2012-11

Completion

2013-07

Publications

• Lazzeroni M, Guerrieri-Gonzaga A, Serrano D, Cazzaniga M, Mora S, Casadio C, Jemos C, Pizzamiglio M, Cortesi L, Radice D, Bonanni B. Breast ductal lavage for biomarker assessment in high risk women: rationale, design and methodology of a randomized phase II clinical trial with nimesulide, simvastatin and placebo. BMC Cancer. 2012 Dec 5;12:575. doi: 10.1186/1471-2407-12-575.

Drugs

Indications