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Recruiting Phase 3 Interventional

Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

ClinicalTrials.gov ID: NCT07085767

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.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 6:51 AM EDT

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
Lead sponsor
Olema Pharmaceuticals, Inc.
Industry
Enrollment
1,000 participants

Conditions and interventions

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
Aug 16, 2026

2025 – 2032

United States locations

U.S. sites
47
U.S. states
27
U.S. cities
47
Facility City State ZIP Site status
Clinical Trial Site Hot Springs Arkansas 71913 Active, not 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 San Francisco California 94115 Recruiting
Clinical Trial Site Santa Barbara California 93105 Active, not recruiting
Clinical Trial Site Vallejo California 94589 Recruiting
Clinical Trial Site Aurora Colorado 80045 Active, not 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 Active, not recruiting
Clinical Trial Site Scarborough Maine 04074 Recruiting
Clinical Trial Site Annapolis Maryland 21401 Recruiting
Clinical Trial Site Catonsville Maryland 21228 Active, not recruiting
Clinical Trial Site Burlington Massachusetts 01805 Recruiting
Clinical Trial Site Minneapolis Minnesota 55404 Recruiting
Clinical Trial Site Jackson Mississippi 39216 Active, not recruiting
Clinical Trial Site Kansas City Missouri 64132 Recruiting
Clinical Trial Site Santa Fe New Mexico 87505 Recruiting
Clinical Trial Site New York New York 10032 Active, not recruiting
Clinical Trial Site Charlotte North Carolina 28204 Recruiting
Clinical Trial Site Cincinnati Ohio 45245 Recruiting
Clinical Trial Site Columbus Ohio 43219 Recruiting
Clinical Trial Site Portland Oregon 97239 Active, not recruiting
Clinical Trial Site Horsham Pennsylvania 19044 Active, not recruiting
Clinical Trial Site Sayre Pennsylvania 18840 Recruiting
Clinical Trial Site Bartlett Tennessee 38133 Recruiting
Clinical Trial Site Knoxville Tennessee 37909 Active, not 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 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 Active, not recruiting
Clinical Trial Site Salt Lake City Utah 84106 Active, not 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 Vancouver Washington 98684 Active, not recruiting
Clinical Trial Site Milwaukee Wisconsin 52336 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 134 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 Aug 16, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07085767 live on ClinicalTrials.gov.

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