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Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)
EU CTIS ID: 2024-515445-42-00
What this study is testing
Evaluate the efficacy of elacestrant relative to standard endocrine therapy in terms of Invasive breast cancer-free survival (IBCFS) in participants with node-positive, ER+, HER2- early breast cancer with high risk of recurrence.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histopathologically or cytologically confirmed ER+ (≥ 10% by immunohistochemistry [IHC]), HER2- [IHC 0, 1+, or 2+, and in situ hybridization [ISH] negative (not amplified). ISH-negative without IHC testing will also be eligible] on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer, without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
- Participants who are currently taking endocrine therapy and have received at least 24 months but not more than 60 months of endocrine therapyat the time of randomization (C1D1), with or without a CDK4/6i, and with or without an LHRH agonist. Participants who received prior CDK4/6i or a poly ADP-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments as per the washout period prior to randomization.
You likely can't join if
- Participants with inflammatory breast cancer.
- History of any prior (ipsilateral and/or contralateral) invasive breast cancer.
- Participants who have had more than 6-months continuous interruption of prior SoC adjuvant endocrine therapy or who are off current adjuvant endocrine therapy more than 6 months prior to randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong
- United States
- United Kingdom
- Israel
- Switzerland
- Brazil
- Singapore
- Canada
- Taiwan
- Argentina
- Turkey
- Malaysia
- Korea, Republic of
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong; United States; United Kingdom; Israel; Switzerland; Brazil and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.