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

Sponsor: Olema Pharmaceuticals, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07085767

This phase 3 trial evaluates the efficacy and safety of palazestrant with ribociclib versus letrozole with ribociclib in ER+, HER2- advanced breast cancer. It involves 1,000 adults with no prior systemic treatment, randomized 1:1. Participants must have evaluable disease, ECOG 0-1, and adequate organ function. Interventions include palazestrant, ribociclib, and respective placebos.

Patient Parameters

Program Overview

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.

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.

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.

Locations

FACILITYZIPCITYSTATE
Clinical Trial Site50010AmesIowa
Clinical Trial Site04074ScarboroughMaine
Clinical Trial Site64132Kansas CityMissouri
Clinical Trial Site87505Santa FeNew Mexico
Clinical Trial Site18840SayrePennsylvania
Clinical Trial Site37203Tennessee CityTennessee
Clinical Trial Site84106Salt Lake CityUtah

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