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

Recruiting · NCT07085767 · Interventional (participants receive a specific treatment) · Lead sponsor: Olema Pharmaceuticals, Inc.

View the official record on ClinicalTrials.gov →

Breast Cancer

Interventions studied

LetrozoleLetrozole-matching placeboPalazestrantPalazestrant matching-placeboRibociclib

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 27 US states.

Clinical Trial Site - Hot Springs, Arkansas, United States
Clinical Trial Site - Beverly Hills, California, United States
Clinical Trial Site - La Jolla, California, United States
Clinical Trial Site - Los Alamitos, California, United States
Clinical Trial Site - San Francisco, California, United States
Clinical Trial Site - Santa Barbara, California, United States
Clinical Trial Site - Vallejo, California, United States
Clinical Trial Site - Aurora, Colorado, United States
Clinical Trial Site - Denver, Colorado, United States
Clinical Trial Site - New Haven, Connecticut, United States
Clinical Trial Site - Tampa, Florida, United States
Clinical Trial Site - Marietta, Georgia, United States
Clinical Trial Site - Honolulu, Hawaii, United States
Clinical Trial Site - Peoria, Illinois, United States
Clinical Trial Site - Urbana, Illinois, United States
Clinical Trial Site - Ames, Iowa, United States
Clinical Trial Site - Scarborough, Maine, United States
Clinical Trial Site - Annapolis, Maryland, United States
Clinical Trial Site - Catonsville, Maryland, United States
Clinical Trial Site - Burlington, Massachusetts, United States
Clinical Trial Site - Minneapolis, Minnesota, United States
Clinical Trial Site - Jackson, Mississippi, United States
Clinical Trial Site - Kansas City, Missouri, United States
Clinical Trial Site - Santa Fe, New Mexico, United States
Clinical Trial Site - New York, New York, United States
Clinical Trial Site - Charlotte, North Carolina, United States
Clinical Trial Site - Cincinnati, Ohio, United States
Clinical Trial Site - Columbus, Ohio, United States
Clinical Trial Site - Portland, Oregon, United States
Clinical Trial Site - Horsham, Pennsylvania, United States
Clinical Trial Site - Sayre, Pennsylvania, United States
Clinical Trial Site - Bartlett, Tennessee, United States
Clinical Trial Site - Knoxville, Tennessee, United States
Clinical Trial Site - Mount Juliet, Tennessee, United States
Clinical Trial Site - Nashville, Tennessee, United States
Clinical Trial Site - Tennessee City, Tennessee, United States
Clinical Trial Site - Denton, Texas, United States
Clinical Trial Site - El Paso, Texas, United States
Clinical Trial Site - Houston, Texas, United States
Clinical Trial Site - San Antonio, Texas, United States
Clinical Trial Site - Salt Lake City, Utah, United States
Clinical Trial Site - Fort Belvoir, Virginia, United States
Clinical Trial Site - Midlothian, Virginia, United States
Clinical Trial Site - Norfolk, Virginia, United States
Clinical Trial Site - Olympia, Washington, United States
Clinical Trial Site - Vancouver, Washington, United States
Clinical Trial Site - Milwaukee, Wisconsin, United States
Clinical Trial Site - Bobigny, France
Clinical Trial Site - Pátrai, Achaia, Greece
Clinical Trial Site - Alicante, Alicante, Spain
Clinical Trial Site - Athens, Attica, Greece
Clinical Trial Site - Pierre-Bénite, Auvergne-Rhône-Alpes, France
Clinical Trial Site - Bangkok, Bangkok, Thailand
Clinical Trial Site - Dusit, Bangkok, Thailand
Clinical Trial Site - Barcelona, Barcelona, Spain
Clinical Trial Site - Barcelona, Barcelona, Spain
Clinical Trial Site - Barcelona, Barcelona, Spain
Clinical Trial Site - Brest, Brittany Region, France
Clinical Trial Site - Plérin, Brittany Region, France
Clinical Trial Site - Brussels, Brussels Capital, Belgium

Showing 60 of 181 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →