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

a study on Breast Cancer HER2

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Jo Chien (ucsf)
Headshot of Jo Chien
Jo Chien

Description

Summary

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.

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)

Details

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.

Keywords

Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma, Randomized, Multicenter, Double-Blind, Active-Controlled, Phase 3, Palazestrant, Complete Estrogen Receptor Antagonist (CERAN), Selective Estrogen Receptor Degrader (SERD), Ribociclib, CDK4/6i, Letrozole, Aromatase inhibitors, Antineoplastic agents, Breast Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Clinical Trial Site accepting new patients
    San Francisco California 94115 United States
  • Clinical Trial Site accepting new patients
    Beverly Hills California 90211 United States
  • Clinical Trial Site accepting new patients
    La Jolla California 92093 United States
  • Clinical Trial Site accepting new patients
    San Francisco California 94158 United States
  • Clinical Trial Site accepting new patients
    Oakland California 94611 United States
  • Clinical Trial Site accepting new patients
    Los Alamitos California 90720 United States
  • Clinical Trial Site accepting new patients
    Walnut Creek California 94596 United States
  • Clinical Trial Site accepting new patients
    Vallejo California 94589 United States

Lead Scientist at University of California Health

  • Jo Chien (ucsf)
    Dr. Chien specializes in the management and treatment of patients with breast cancer. She is Professor of Medicine at UCSF and the Helen Diller Family Comprehensive Cancer Center. Dr. Chien received her undergraduate degree from Stanford University and medical degree from Harvard Medical School.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Olema Pharmaceuticals, Inc.
Links
Olema Publications
ID
NCT07085767
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1000 study participants
Last Updated
Contact us about this trial