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)
Study identification
- NCT ID
- NCT07085767
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Olema Pharmaceuticals, Inc.
- Industry
- Enrollment
- 1,000 participants
Conditions and interventions
Conditions
Interventions
- Letrozole Drug
- Letrozole-matching placebo Drug
- Palazestrant Drug
- Palazestrant matching-placebo Drug
- Ribociclib 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 2, 2025
- Primary completion
- Nov 30, 2028
- Completion
- Dec 31, 2031
- Last update posted
- Apr 15, 2026
2025 – 2032
United States locations
- U.S. sites
- 21
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Trial Site | Hot Springs | Arkansas | 71913 | Active, not recruiting |
| Clinical Trial Site | Santa Barbara | California | 93105 | Active, not recruiting |
| Clinical Trial Site | Denver | Colorado | 80220 | Recruiting |
| Clinical Trial Site | Peoria | Illinois | 61615 | Active, not recruiting |
| Clinical Trial Site | Ames | Iowa | 50010 | Active, not recruiting |
| Clinical Trial Site | Scarborough | Maine | 04074 | Recruiting |
| Clinical Trial Site | Annapolis | Maryland | 21401 | Active, not recruiting |
| Clinical Trial Site | Kansas City | Missouri | 64132 | Recruiting |
| Clinical Trial Site | Santa Fe | New Mexico | 87505 | Recruiting |
| Clinical Trial Site | Columbus | Ohio | 43219 | Recruiting |
| Clinical Trial Site | Horsham | Pennsylvania | 19044 | Active, not recruiting |
| Clinical Trial Site | Sayre | Pennsylvania | 18840 | Recruiting |
| Clinical Trial Site | Knoxville | Tennessee | 37909 | Active, not recruiting |
| Clinical Trial Site | Tennessee City | Tennessee | 37203 | Active, not recruiting |
| Clinical Trial Site | Denton | Texas | 76201 | Active, not recruiting |
| Clinical Trial Site | El Paso | Texas | 79902 | Active, not recruiting |
| Clinical Trial Site | Houston | Texas | 77024 | Active, not recruiting |
| Clinical Trial Site | San Antonio | Texas | 78229 | Active, not recruiting |
| Clinical Trial Site | Salt Lake City | Utah | 84106 | Not yet recruiting |
| Clinical Trial Site | Olympia | Washington | 98502 | Active, not recruiting |
| Clinical Trial Site | Vancouver | Washington | 98684 | Active, not 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 64 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 Apr 15, 2026 · Synced May 5, 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 protocol, eligibility criteria, and contact information for NCT07085767 live on ClinicalTrials.gov.