๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-29

A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer (NCT05154487)

Phase 2 Study of Alpelisib and Fulvestrant for PIK3CA-mutated Estrogen Receptor (ER)-Positive Endometrioid Endometrial Cancers

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: GOG Foundation

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

This is a 2 stage multi-center study designed to evaluate the efficacy of the combination of alpelisib and fulvestrant in patients with PIK3CA-mutated ER-positive endometrioid endometrial cancers by estimating the objective response rate (ORR). Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal.

Who can join: Review the eligibility criteria below.

Location: City of Hope โ€” Duarte, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

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 (21 Sites)

  • City of Hope โ€” Duarte, California
  • Mount Sinai Medical Center โ€” Miami Beach, Florida
  • AdventHealth Gynecologic Oncology โ€” Orlando, Florida
  • Tampa General Hospital โ€” Tampa, Florida
  • Moffit Cancer Center at International Plaza โ€” Tampa, Florida
  • Moffitt Cancer Center โ€” Tampa, Florida
  • Moffit Cancer Center at Wesley Chapel โ€” Wesley Chapel, Florida
  • Endeavor Health โ€” Evanston, Illinois
  • Endeavor Health Clinical Operations, Glenbrook Hospital โ€” Glenview, Illinois
  • Endeavor Health Clinical Operations, Highland Park Hospital โ€” Highland Park, Illinois
  • Ascension St. Vincent โ€” Indianapolis, Indiana
  • Norton Cancer Institute โ€” Louisville, Kentucky
  • Johns Hopkins Medicine โ€” Baltimore, Maryland
  • Northwell Health Cancer Institute โ€” Lake Success, New York
  • QCC- Northwell Health Physicians Partners Medical โ€” Rego Park, New York
  • Kettering Health Cancer Center โ€” Kettering, Ohio
  • Oklahoma Cancer Specialists and Research Institute, LLC โ€” Tulsa, Oklahoma
  • Legacy Good Samaritan Medical Center โ€” Portland, Oregon
  • Legacy Meridian Park Medical Center โ€” Tualatin, Oregon
  • Legacy Salmon Creek Medical Center โ€” Vancouver, Washington
  • University of Wisconsin Clinical Science Center โ€” Madison, Wisconsin

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 826-4673

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  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†—