๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-10

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

A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

๐Ÿ”ต Active, Not Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Stemline Therapeutics, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer. The phase 1b part of the trial will determine the recommended Phase 2 dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.

Who can join: Review the eligibility criteria below.

Location: Dothan Hematology and Oncology โ€” Dothan, Alabama

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (83 Sites)

Showing the first 25 of 83 sites.

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

๐Ÿ’ฐ 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 ยง 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.

Explore by condition: All Breast Cancer clinical trials

๐Ÿ’ก 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.
๐Ÿ›๏ธ View Official NIH Record โ†—