STAR Trial Hits Its Numbers

By BIO-IT World

January 15, 2005 | Last June, the National Surgical Adjuvant Breast and Bowel Project (NSABBP) reached an important milestone. The private, not-for-profit organization, funded by the National Cancer Institute, had accomplished its goal of enrolling some 19,000 post-menopausal women at increased risk of breast cancer in an important head-to-head trial of two agents, Tamoxifene and Reloxifene, known as the STAR trial.

The project was unique in a number of ways. First, it was the first large national trial to attempt a head-to-head comparison of two agents in seeking not to cure, but to prevent, breast cancer in a population at increased risk.

Second, the trial, which is expected to report its results in the summer of 2006, relied substantially on cooperation from employers in reaching its accrual target. "In order to reach statistically significant results, and to answer the study questions, you need to enroll a lot more women in prevention trials as compared to treatment studies," says Lori Garvey, director of public relations and communications for the NSABP.

The high enrollment target was set because the sponsors of the STAR trial hope to report on whether daily use of the agents decreases risk of developing breast cancer over five years. Thus, information regarding the studies was made available to employees of large companies such as Ford, General Motors, and Mary K.

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