OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
Public ClinicalTrials.gov record NCT06016738. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06016738
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 510 participants
Conditions and interventions
Conditions
Interventions
- Palazestrant Drug
- Fulvestrant Drug
- Anastrozole Drug
- Letrozole Drug
- Exemestane Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 15, 2023
- Primary completion
- Oct 30, 2026
- Completion
- Feb 28, 2028
- Last update posted
- Aug 12, 2026
2023 – 2028
United States locations
- U.S. sites
- 47
- U.S. states
- 23
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Trial Site | Tucson | Arizona | 85719 | — |
| Clinical Trial Site | Fountain Valley | California | 92708 | — |
| Clinical Trial Site | Glendale | California | 91204 | — |
| Clinical Trial Site | La Jolla | California | 92093 | — |
| Clinical Trial Site | Los Alamitos | California | 90720 | — |
| Clinical Trial Site | Los Angeles | California | 90027 | — |
| Clinical Trial Site | Whittier | California | 90602 | — |
| Clinical Trial Site | Aurora | Colorado | 80045 | — |
| Clinical Trial Site | Denver | Colorado | 80218 | — |
| Clinical Trial Site | Golden | Colorado | 80401 | — |
| Clinical Trial Site | Grand Junction | Colorado | 81505 | — |
| Clinical Trial Site | Danbury | Connecticut | 06810 | — |
| Clinical Trial Site | Newark | Delaware | 19713 | — |
| Clinical Trials Site | Jacksonville | Florida | 32223 | — |
| Clinical Trial Site | Margate | Florida | 33063 | — |
| Clinical Trial Site | Orlando | Florida | 32804 | — |
| Clinical Trial Site | Plantation | Florida | 33324 | — |
| Clinical Trial Site | Tamarac | Florida | 33321 | — |
| Clinical Trial Site | Atlanta | Georgia | 30322 | — |
| Clinical Trial Site | Chicago | Illinois | 60616-2315 | — |
| Clinical Trial Site | Chicago | Illinois | 60637 | — |
| Clinical Trial Site | Urbana | Illinois | 61801 | — |
| Clinical Trial Site | Baton Rouge | Louisiana | 70809 | — |
| Clinical Trial Site | New Orleans | Louisiana | 70112 | — |
| Clinical Trial Site | Baltimore | Maryland | 21201 | — |
| Clinical Trial Site | Boston | Massachusetts | 02111 | — |
| Clinical Trial Site | Detroit | Michigan | 48202 | — |
| Clinical Trial Site | Saint Louis Park | Minnesota | 55426 | — |
| Clinical Trial Site | Woodbury | Minnesota | 55125 | — |
| Clinical Trial Site | Lincoln | Nebraska | 68516 | — |
| Clinical Trial Site | Farmington | New Mexico | 87401 | — |
| Clinical Trial Site | New York | New York | 10032 | — |
| Clinical Trial Site | Port Jefferson Station | New York | 11776 | — |
| Clinical Trial Site | Dayton | Ohio | 45415 | — |
| Clinical Trial Site | Toledo | Ohio | 43623 | — |
| Clinical Trial Site | Portland | Oregon | 97239 | — |
| Clinical Trial Site | Sayre | Pennsylvania | 18840 | — |
| Clinical Trial Site | Nashville | Tennessee | 37203 | — |
| Clinical Trial Site | Nashville | Tennessee | 37208 | — |
| Clinical Trial Site | Nashville | Tennessee | 37232 | — |
| Clinical Trial Site | Dallas | Texas | 75246 | — |
| Clinical Trial Site | Dallas | Texas | 75390 | — |
| Clinical Trial Site | Houston | Texas | 77054 | — |
| Clinical Trial Site | Webster | Texas | 77598 | — |
| Clinical Trial Site | Ogden | Utah | 84405 | — |
| Clinical Trial Site | Spokane | Washington | 99204 | — |
| Clinical Trial Site | Spokane | Washington | 99208 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 186 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06016738, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06016738 live on ClinicalTrials.gov.