Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
Public ClinicalTrials.gov record NCT07085767. 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, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
Study identification
- NCT ID
- NCT07085767
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,000 participants
Conditions and interventions
Conditions
Interventions
- Palazestrant Drug
- Letrozole-matching placebo Drug
- Ribociclib Drug
- Letrozole Drug
- Palazestrant matching-placebo 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 3, 2025 (Actual)
- Primary completion
- Dec 2028 (Estimated)
- Completion
- Jan 2032 (Estimated)
- Last update posted
- Sep 23, 2026
2025 – 2032
United States locations
- U.S. sites
- 62
- U.S. states
- 29
- U.S. cities
- 57
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Trial Site | Hot Springs | Arkansas | 71913 | Recruiting |
| Clinical Trial Site | Beverly Hills | California | 90211 | Recruiting |
| Clinical Trial Site | La Jolla | California | 92093 | Recruiting |
| Clinical Trial Site | Los Alamitos | California | 90720 | Recruiting |
| Clinical Trial Site | Oakland | California | 94611 | Recruiting |
| Clinical Trial Site | Roseville | California | 95661 | Recruiting |
| Clinical Trial Site | San Francisco | California | 94115 | Recruiting |
| Clinical Trial Site | San Francisco | California | 94158 | Recruiting |
| Clinical Trial Site | Santa Barbara | California | 93105 | Recruiting |
| Clinical Trial Site | Santa Clara | California | 95051 | Recruiting |
| Clinical Trial Site | Vallejo | California | 94589 | Recruiting |
| Clinical Trial Site | Walnut Creek | California | 94596 | Recruiting |
| Clinical Trial Site | Aurora | Colorado | 80045 | Recruiting |
| Clinical Trial Site | Denver | Colorado | 80220 | Recruiting |
| Clinical Trial Site | New Haven | Connecticut | 06511 | Recruiting |
| Clinical Trial Site | Tampa | Florida | 33612 | Recruiting |
| Clinical Trial Site | Marietta | Georgia | 30060 | Recruiting |
| Clinical Trial Site | Honolulu | Hawaii | 96813 | Recruiting |
| Clinical Trial Site | Peoria | Illinois | 61615 | Recruiting |
| Clinical Trial Site | Urbana | Illinois | 61801 | Recruiting |
| Clinical Trial Site | Ames | Iowa | 50010 | Withdrawn |
| Clinical Trial Site | Scarborough | Maine | 04074 | Recruiting |
| Clinical Trial Site | Annapolis | Maryland | 21401 | Recruiting |
| Clinical Trial Site | Baltimore | Maryland | 21201 | Recruiting |
| Clinical Trial Site | Baltimore | Maryland | 21205 | Recruiting |
| Clinical Trial Site | Catonsville | Maryland | 21228 | Recruiting |
| Clinical Trial Site | Burlington | Massachusetts | 01805 | Recruiting |
| Clinical Trial Site | Ann Arbor | Michigan | 48109 | Recruiting |
| Clinical Trial Site | Minneapolis | Minnesota | 55404 | Recruiting |
| Clinical Trial Site | Jackson | Mississippi | 39216 | Recruiting |
| Clinical Trial Site | Kansas City | Missouri | 64132 | Recruiting |
| Clinical Trial Site | Lebanon | New Hampshire | 03756 | Recruiting |
| Clinical Trial Site | Santa Fe | New Mexico | 87505 | Recruiting |
| Clinical Trial Site | New York | New York | 10029 | Recruiting |
| Clinical Trial Site | New York | New York | 10032 | Recruiting |
| Clinical Trial Site | Charlotte | North Carolina | 28204 | Recruiting |
| Clinical Trial Site | Durham | North Carolina | 27710 | Recruiting |
| Clinical Trial Site | Cincinnati | Ohio | 45245 | Recruiting |
| Clinical Trial Site | Columbus | Ohio | 43212 | Recruiting |
| Clinical Trial Site | Columbus | Ohio | 43219 | Recruiting |
| Clinical Trial Site | Portland | Oregon | 97239 | Recruiting |
| Clinical Trial Site | Horsham | Pennsylvania | 19044 | Recruiting |
| Clinical Trial Site | Sayre | Pennsylvania | 18840 | Recruiting |
| Clinical Trial Site | Bartlett | Tennessee | 38133 | Recruiting |
| Clinical Trial Site | Knoxville | Tennessee | 37909 | Recruiting |
| Clinical Trial Site | Mount Juliet | Tennessee | 37122 | Recruiting |
| Clinical Trial Site | Nashville | Tennessee | 37232 | Recruiting |
| Clinical Trial Site | Tennessee City | Tennessee | 37203 | Recruiting |
| Clinical Trial Site | Dallas | Texas | 75235 | Recruiting |
| Clinical Trial Site | Dallas | Texas | 75390 | Recruiting |
| Clinical Trial Site | Denton | Texas | 76201 | Recruiting |
| Clinical Trial Site | El Paso | Texas | 79902 | Recruiting |
| Clinical Trial Site | Houston | Texas | 77024 | Recruiting |
| Clinical Trial Site | San Antonio | Texas | 78229 | Recruiting |
| Clinical Trial Site | Salt Lake City | Utah | 84106 | Recruiting |
| Clinical Trial Site | Fort Belvoir | Virginia | 22060 | Recruiting |
| Clinical Trial Site | Midlothian | Virginia | 23114 | Recruiting |
| Clinical Trial Site | Norfolk | Virginia | 23502 | Recruiting |
| Clinical Trial Site | Olympia | Washington | 98502 | Recruiting |
| Clinical Trial Site | Seattle | Washington | 98109 | Recruiting |
| Clinical Trial Site | Vancouver | Washington | 98684 | Recruiting |
| Clinical Trial Site | Milwaukee | Wisconsin | 52336 | Recruiting |
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 138 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07085767, 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 Sep 23, 2026 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07085767 live on ClinicalTrials.gov.