Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer (NCT05508906)
A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, With the mTOR Inhibitor Everolimus, or With CDK4 Inhibitor Atirmociclib in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). Treatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation). Treatment Group 3: Palazestrant (OP-1250) in combination with everolimus. Treatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib.
Who can join: Review the eligibility criteria below.
Location: Banner MD Anderson Cancer Center — Gilbert, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- University of California San Francisco Health — San Francisco, California
- University of Colorado Cancer Center — Aurora, Colorado
- Advent Health Hematology and Oncology — Orlando, Florida
- University of Iowa — Iowa City, Iowa
- Dana Farber Cancer Institute — Boston, Massachusetts
- Henry Ford Health — Detroit, Michigan
- Regents of the University of Minnesota — Minneapolis, Minnesota
- Washington University, School of Medicine — St Louis, Missouri
- Ichan School of Medicine at Mount Sinai — New York, New York
- Atrium Health Levine Cancer Institute — Charlotte, North Carolina
- Henry-Joyce Cancer Clinic, The Vanderbilt Clinic — Nashville, Tennessee
- MD Anderson Cancer Center — Houston, Texas
- Northwest Medical Specialties — Tacoma, Washington
- Macquarie Health — Sydney, New South Wales
- Breast Cancer Research Center- Western Australia — Nedlands, Western Australia
📞 Contact the Study Coordinator
Phone: (415) 651-7206
Email: medinfo@olema.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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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Explore by condition: All Metastatic Breast Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.