ELEGANT Clinical Trial for Early-Stage Breast Cancer
Updated on March 5, 2026
Trial details
Overview: The ELEGANT clinical trial is comparing the effect of switching to Orserdu (chemical name: elacestrant) versus continuing with a standard hormonal therapy medicine — either Arimidex (chemical name: anastrozole), Femara (chemical name: letrozole), Aromasin (chemical name: exemestane), or tamoxifen — for people who have already taken one of those medicines for two to five years. It’s designed for adults with early-stage, estrogen receptor-positive, HER2-negative breast cancer that had spread to at least one lymph node when it was first detected.
Phase: Phase III; phase III trials compare the safety and effectiveness of a new treatment to the current standard of care. Phase III trials are usually large — some involve thousands of people — and are done at many places in the United States and around the world.
Number of people to enroll: 4,220
ClinicalTrials.gov ID number: NCT06492616
Sponsor of the trial: Stemline Therapeutics
Who is the trial for?
The ELEGANT clinical trial is enrolling adults (18 and up) with early-stage estrogen receptor-positive, HER2-negative breast cancer that has spread to at least one lymph node and has a high risk of recurrence (coming back) after surgery.
People in the study should already have taken hormonal therapy — either an aromatase inhibitor or tamoxifen — for between two and five years.
Why is the trial being done?
The ELEGANT clinical trial is designed to see if Orserdu offers more benefits than an aromatase inhibitor or tamoxifen for early-stage estrogen receptor-positive, HER2-negative breast cancer with a high risk of recurrence.
Orserdu is a selective estrogen receptor downregulator (SERD), a medicine that blocks estrogen from attaching to cancer cells in the breast and telling the cells to grow. Orserdu is approved to treat metastatic estrogen receptor-positive, HER2-negative breast cancer that has an ESR1 mutation. This trial is studying whether Orderdu can be used to treat early-stage breast cancer.
In the study, people will either:
stop taking the hormonal therapy medicine they’ve been taking for two to five years and start taking Orderdu for five years
continue taking their current hormonal therapy medicine
Specific eligibility requirements
People are eligible for the ELEGANT study if they have been diagnosed with early-stage estrogen receptor-positive, HER2-negative breast cancer that has spread to at least one lymph node and has a high risk of recurrence, and have taken hormonal therapy — an aromatase inhibitor or tamoxifen — for at least two years but not more than five years. People who’ve previously taken a CDK4/6 inhibitor are allowed in the study.
People are not eligible for the ELEGANT study if they:
have had invasive breast cancer before, in either breast
have had another type of cancer within the previous three years, except for certain low-grade cancers that have already been treated
haven’t been taking hormonal therapy for six months or more
Read the detailed eligibility requirements.
Side effects
Side effects of Orserdu
The most common side effects of Orserdu are:
Side effects of hormonal therapy medicines in this study
The most common side effects of hormonal therapy are:
hot flashes
joint and bone pain
Study locations
The ELEGANT study is being conducted at dozens of sites across the United States.
For more information or to enroll
Call Stemline Trials at 1-877-332-7961 or email clinicaltrials@menarinistemline.com.