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ClinicalTrials.gov record
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.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 11:55 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 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

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07085767 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →