This trial is aiming to determine how effective a new medication called elacestrant is for treating advanced breast cancer. The main outcome that will be measured is how long the patients go without the disease progressing. This study is being conducted in Illinois, United States.
Some breast cancers grow in response to the female hormone estrogen. These are called estrogen receptor positive (ER+). Current standard treatment for ER+ breast cancer is to use an aromatase inhibitor and fulvestrant (Faslodex). However, some patients have disease progression with this treatment. For these patients, newer treatments are researched.
Elacestrant is a newer drug that works in a similar way as fulvestrant. It blocks the action of the estrogen hormone on cancer cells. This stops cancer cell growth. It is still not known if treatment with elacestrant is any better than the current standard treatment.
This trial is aiming to test the effectiveness of elacestrant compared to the standard treatment for advanced breast cancer. The main outcome that will be measured is how long it takes for cancer to start growing again.
Who are they looking for?
This study is recruiting 466 patients with advanced breast cancer. Only post-menopausal women can participate and male patients who agree not to conceive or donate sperm during the study.
Patients previously treated with elacestrant or another hormonal therapy study drug will not be allowed to participate. Patients must not have had other cancer treatments for 28 days before the trial begins.
How will it work
In this trial, patients will be randomly assigned to one of two groups. Group one will receive one of the standard of care drugs available. Group two will receive treatment with elacestrant tablets once a day. Patients will be followed up to 24 months.
The outcomes that will be measured are overall survival and survival without cancer growing or spreading.