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RecruitingPhase 3

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This phase 3 study compares palazestrant plus ribociclib with letrozole plus ribociclib to see how well they work and how safe they are. It is for adults with advanced ER-positive, HER2-negative breast cancer who have not had whole-body cancer treatment for advanced disease.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults of any sex. Women may join before, during, or after menopause.
  • Breast cancer that uses estrogen to grow (ER-positive) and does not have high levels of HER2 protein (HER2-negative). It must have spread nearby or farther away and cannot be cured with treatment.
  • Cancer that can be measured or assessed, including cancer that has spread only to bones.
  • Cancer that was advanced when first found, or came back more than 12 months after finishing hormone treatment given after initial treatment. That treatment may have included drugs called CDK4/6 inhibitors.
  • Fully active, or able to walk and do light work but limited in heavy activity (ECOG score 0 or 1).
  • Blood counts, liver function, and kidney function must meet study requirements.
  • Men and women before or during menopause must be willing to take a hormone-blocking drug called a GnRH or LHRH agonist.

Who can't join

  • Cancer came back while taking hormone treatment given after initial treatment.
  • Current or past whole-body cancer treatment for advanced ER-positive, HER2-negative breast cancer.
  • Past treatment with fulvestrant, elacestrant, or an experimental hormone treatment at any stage.
  • Past allergic reactions to a study treatment.
  • A medical reason that makes letrozole or ribociclib unsafe to take.
  • Cancer spread to the brain or spinal cord that causes symptoms, cancer in their lining, or pressure on the spinal cord that needs immediate treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (62)

AR

CA

CO

CT

FL

GA

HI

IA

IL

MA

MD

ME

MI

MN

MO

MS

NC

NH

NM

NY

OH

OR

PA

TN

TX

UT

VA

WA

WI