Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer (NCT05563220)

🧪 Interventions in This Study

• Elacestrant (DRUG)
• Alpelisib (DRUG)
• Everolimus (DRUG)
• Ribociclib (DRUG)
• Palbociclib (DRUG)
• Capivasertib (DRUG)
• Abemaciclib (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Participant has signed the informed consent before all study specific activities are conducted.
2. Women or men aged ≥18 years (or the minimum age of consent in accordance with the local law), at the time of informed consent signature. Female participants may be of any menopausal status.
3. Postmenopausal status is defined as follows or in accordance with local regulations:
4. Age ≥60 years or
5. Age \<60 years and amenorrhea for 12 or more months (without an alternative cause) and follicle-stimulating hormone value and an estradiol level within the postmenopausal range per local laboratory reference or
6. Documentation of bilateral oophorectomy, at least 1 month before first dose of trial therapy.
7. Premenopausal and perimenopausal women (who do not fit postmenopausal criteria) and men must be receiving a luteinizing hormone-releasing hormone (LHRH) agonist and must be initiated at least 3 weeks (4 depending on local label) before the start of trial therapy and are planning to continue LHRH agonist treatment during the study treatment.
8. Histopathological or cytological confirmed ER+, HER2-, breast cancer, per local laboratory, as per the American Society of Clinical Oncology/College of American Pathologists guidelines. Note: In the context of this trial, ER status will be considered positive if ≥10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry, with or without progesterone positivity.
9. Documented radiological disease progression during or after the most recent therapy.
10. At least 1 measurable lesion as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Tumor lesions previously irradiated or subjected to any locoregional treatment will only be considered measurable if there is clear, documented progression at the treated site. For participants with bone only disease, lesions: must be lytic or mixed (lytic + blastic / sclerotic), confirmed and accurately assessed by computed tomography or magnetic resonance imaging, and must have an identifiable soft tissue component meeting the definition of measurability per RECIST v1.1. Note: participants with blastic / sclerotic bone lesions only are not eligible.
11. Eastern Cooperative Oncology Group performance status of 0 or 1.
12. Participant has adequate bone marrow and organ function, as defined by the following laboratory values:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (83 Sites)

Showing the first 25 of 83 sites.

• Dothan Hematology and Oncology — Dothan, Alabama
• Mayo Clinic - Arizona — Phoenix, Arizona
• Highlands Oncology Group — Springdale, Arkansas
• City of Hope National Medical Center — Duarte, California
• OPN Healthcare (Los Alamitos Location) — Los Alamitos, California
• Cedars Sinai — Los Angeles, California
• UCLA UCLA Hem/Onc - Clinical Research Unit — Los Angeles, California
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California
• TOI Clinical Research — Whittier, California
• Rocky Mountain Cancer Centers — Lone Tree, Colorado
• George Washington Cancer Center — Washington D.C., District of Columbia
• Advent Health (Florida Hospital) - Altamonte Springs — Altamonte Springs, Florida
• Mayo Clinic - Jacksonville — Jacksonville, Florida
• Northwestern Feinberg Scholl of Medicine Prentice Women's Hospital — Chicago, Illinois
• MD Alliance for Multispecialty Research, LLC — Merriam, Kansas
• Johns Hopkins School of Medicine — Baltimore, Maryland
• Massachusetts General Hospital — Boston, Massachusetts
• Dana Farber Cancer Institute — Boston, Massachusetts
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan
• Mayo Clinic - Rochester — Rochester, Minnesota
• Washington University School of Medicine in St. Louis — St Louis, Missouri
• Astera Cancer Care — East Brunswick, New Jersey
• Summit Medical Group — Florham Park, New Jersey
• Cooperman Barnabas Medical Center — New Brunswick, New Jersey
• NYU Langone Health — New York, New York

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.