Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult female or male participants. - ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy. - Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease). - De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Adequate hematologic, hepatic, and renal functions. - Female participants can be pre-, peri- or postmenopausal. - Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.

Exclusion Criteria

  • Disease recurrence during adjuvant endocrine therapy - Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer. - Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting. - History of allergic reactions to study treatment. - Any contraindications to letrozole and ribociclib. - Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Palazestrant 		Participants will receive palazestrant, ribociclib and letrozole-matching placebo
  • Drug: Palazestrant
    Participants will be treated with palazestrant 90 mg once daily on a 4-week (28-day) cycle.
    Other names:
    • OP-1250
  • Drug: Letrozole-matching placebo
    Participants will be treated with letrozole-matching placebo once daily on a 4-week (28 day) cycle
  • Drug: Ribociclib
    Participants will be treated with ribociclib 600 mg once daily on Days 1-21 of a 4-week (28 day) cycle.
Active Comparator
Letrozole 		Participants will receive letrozole, ribociclib and palazestrant-matching placebo
  • Drug: Ribociclib
    Participants will be treated with ribociclib 600 mg once daily on Days 1-21 of a 4-week (28 day) cycle.
  • Drug: Letrozole
    Participants will be treated with letrozole 2.5 mg once daily on a 4-week (28-day) cycle
  • Drug: Palazestrant matching-placebo
    Participants will be treated with palazestrant-matching placebo once daily on a 4-week (28-day) cycle

Recruiting Locations

Clinical Trial Site
San Francisco, California 94115

Clinical Trial Site
Denver, Colorado 80220

Clinical Trial Site
Tampa, Florida 33612

Clinical Trial Site
Marietta, Georgia 30060

Clinical Trial Site
Honolulu, Hawaii 96813

Clinical Trial Site
Peoria, Illinois 61615

Clinical Trial Site
Scarborough, Maine 04074

Clinical Trial Site
Annapolis, Maryland 21401

Clinical Trial Site
Minneapolis, Minnesota 55404

Clinical Trial Site
Kansas City, Missouri 64132

Clinical Trial Site
Santa Fe, New Mexico 87505

Clinical Trial Site
Cincinnati, Ohio 45245

Clinical Trial Site
Columbus, Ohio 43219

Clinical Trial Site
Sayre, Pennsylvania 18840

Clinical Trial Site
Bartlett, Tennessee 38133

Clinical Trial Site
Tennessee City, Tennessee 37203

Clinical Trial Site
Denton, Texas 76201

Clinical Trial Site
El Paso, Texas 79902

Clinical Trial Site
Houston, Texas 77024

Clinical Trial Site
Fort Belvoir, Virginia 22060

Clinical Trial Site
Norfolk, Virginia 23502

Clinical Trial Site
Olympia, Washington 98502

More Details

Status
Recruiting
Sponsor
Olema Pharmaceuticals, Inc.

Study Contact

Olema Pharmaceuticals, Inc.
415-651-7206
OPERA-02@olema.com

Detailed Description

This is an international, multicenter, randomized, double-blind, active-controlled, phase 3 clinical trial. The purpose of this trial is to compare the efficacy and safety of palazestrant in combination with ribociclib +letrozole -matching placebo (Arm A: investigational arm) with letrozole in combination with ribociclib + palazestrant-matching placebo (Arm B: control arm). This trial is seeking adult participants with ER+, HER2- advanced breast cancer who have not received prior systemic anti-cancer treatment for advanced disease. Approximately 1,000 participants will be randomized in a 1:1 ratio to one of the two study arms.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.