ELEGANT/STML-ELA-0422 Study for Breast Cancer Patients

This is a Phase 3, global, multi-center, randomized, open-label study. About 4220 participants will be randomized in a 1:1 ratio to receive the investigational drug elacestrant or continue their current standard of care (SoC) endocrine drug.

Elacestrant stops hormones from attaching to cancer cells and helping them grow. Researchers would like to understand if switching SoC to elacestrant (the study drug) will help to slow down or stop the growth of cancer.

Elacestrant has been approved by the U.S. Food and Drug Administration (FDA, January 2023) for treatment of postmenopausal women or adult men, with ER+/HER2–, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least 1 line of endocrine therapy in the United States. But this research study will look at elacestrant in the early breast cancer setting, among participants who received prior endocrine therapy and have a high risk of the breast cancer coming back (recurring). The FDA has not yet approved elacestrant for this purpose.

The study drug or the SoC will be given in cycles. Each cycle lasts 28 days. The treatment duration is 5 years. It will take a maximum of 8 years to complete this research study, including the safety follow-up and the long-term follow-up.

In order to participate you must meet the following criteria:

• Have confirmed ER-positive, HER2-negative on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases.
• Are considered at high risk of recurrence at initial staging.
• Have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i).
• Have received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments.

You will be excluded from the study if any of the following criteria apply to you:

• Have inflammatory breast cancer.
• Have a history of any prior (ipsilateral and/or contralateral) invasive breast cancer.
• Have a history of malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix.
• Have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who discontinued adjuvant endocrine therapy more than 6 months prior to randomization.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.