Clinical Trial 23907

• Overview

  Study 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)

  Summary:

  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.

  Objective:

  Primary Objective: * To compare PFS, based on a Local Investigator assessment between investigational (palazestrant with ribociclib + letrozolematching placebo) and control (letrozole with ribociclib + palazestrant-matching placebo) arms. Secondary Objectives: * To compare OS between investigational and control arms. * To evaluate PFS, ORR, DOR and CBR based on Blinded Independent Review Committee (BIRC) assessment * To evaluate ORR, DOR, CBR based on Local Investigator assessment * To evaluate safety and tolerability * To evaluate the PK of palazestrant and ribociclib * To evaluate the change from baseline in healthrelated PROs

• Treatments

  Therapies:

  CDK4/6 Inhibitor; Complete estrogen receptor antagonist, CERAN; Selective estrogen receptor degrader, SERD; non-steroidal aromatase inhibitor

  Medications:

  LEE011 (Ribociclib); Letrozole/Placebo (); Palazestrant/Placebo (); Ribociclib ()

• Inclusion 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.
  • Other criteria may apply

• Exclusion Criteria

  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.
  • Other exclusions may apply

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