OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (NCT06016738)
A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)
🩺 Plain-English Summary (8th-Grade Level)
This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.
Who can join: Review the eligibility criteria below.
Location: Clinical Trial Site — Tucson, 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 (233 Sites)
Showing the first 25 of 233 sites.
- Clinical Trial Site — Tucson, Arizona
- Clinical Trial Site — Fountain Valley, California
- Clinical Trial Site — Glendale, California
- Clinical Trial Site — La Jolla, California
- Clinical Trial Site — Los Alamitos, California
- Clinical Trial Site — Los Angeles, California
- Clinical Trial Site — Whittier, California
- Clinical Trial Site — Aurora, Colorado
- Clinical Trial Site — Denver, Colorado
- Clinical Trial Site — Golden, Colorado
- Clinical Trial Site — Grand Junction, Colorado
- Clinical Trial Site — Danbury, Connecticut
- Clinical Trial Site — Newark, Delaware
- Clinical Trials Site — Jacksonville, Florida
- Clinical Trial Site — Margate, Florida
- Clinical Trial Site — Orlando, Florida
- Clinical Trial Site — Plantation, Florida
- Clinical Trial Site — Tamarac, Florida
- Clinical Trial Site — Atlanta, Georgia
- Clinical Trial Site — Chicago, Illinois
- Clinical Trial Site — Chicago, Illinois
- Clinical Trial Site — Urbana, Illinois
- Clinical Trial Site — Baton Rouge, Louisiana
- Clinical Trial Site — New Orleans, Louisiana
- Clinical Trial Site — Baltimore, Maryland
💰 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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- TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B) — Palo Alto, California
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.