Clinical trials have four main phases, each with a specific goal. Phase 1 and 2 studies may look at whether an investigational drug may be safe or if it may cause side effects. Phase 3 studies may compare the investigational drug with other treatments already approved for the same purpose.
When the investigational drug has passed 3 phases, the results are reviewed by regulatory authorities to determine whether the treatment can be approved for patients. Although the drug may be approved for use, it still needs to be monitored. During the final phase, researchers test how well the drug works over a longer time period.
The ELEGANT study is testing an investigational use of elacestrant, a drug that
has already been approved to treat certain people with advanced breast cancer (cancer that has spread to other parts of the body). Researchers will be testing whether the same investigational use could work for people with early-stage breast cancer.
The ELEGANT Study is in Phase 3.