OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

Sponsor: Olema Pharmaceuticals, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06016738

This phase 3 trial evaluates the safety and efficacy of palazestrant (OP-1250) against standard endocrine therapies in ER+, HER2- advanced breast cancer. Eligible adults must have progressed on prior endocrine therapy with a CDK4/6 inhibitor. Participants will receive either palazestrant or standard care drugs like fulvestrant or aromatase inhibitors. The trial includes dose selection and randomization phases.

Patient Parameters

Program Overview

This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.

Description

This is an international, multicenter, randomized, open-label, active-controlled, phase 3 clinical trial. The purpose of this trial is to compare the safety and efficacy of palazestrant (OP-1250) as a single agent to the standard of care endocrine therapy: either fulvestrant or an aromatase inhibitor (anastrozole, letrozole, or exemestane).

This trial is seeking adult participants with ER+, HER2- advanced or metastatic breast cancer whose disease has relapsed or progressed on 1 or 2 prior lines of standard-of-care endocrine therapy for metastatic breast cancer. Prior lines of therapy must include one line of endocrine therapy in combination with a CDK 4/6 inhibitor. In the dose-selection part of the trial, approximately 120 participants will be randomized to one of the two doses of palazestrant or to the standard-of-care endocrine therapy. Thereafter, approximately 390 participants will be randomized to palazestrant at the selected dose or to the standard-of-care endocrine therapy.

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 or bone-only disease).
  • Previously received a CDK4/6 inhibitor in combination with an endocrine therapy in the advanced setting. One additional line of ET as a monotherapy is allowed. Duration of the most recent prior ET must be at least 6 months.
  • 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.

Key

Exclusion Criteria

  • Symptomatic visceral disease, imminent organ failure, or any other reason that makes the participant ineligible for endocrine monotherapy.
  • Previously received chemotherapy in the advanced/metastatic setting.
  • Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy.
  • History of allergic reactions to study treatment.
  • Any contraindications to the selected standard-of-care endocrine therapy in the local prescribing information.
  • Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
  • Clinically significant comorbidities such as significant cardiac or cerebrovascular disease, gastrointestinal disorders that could affect absorption of study treatment.

Locations

FACILITYZIPCITYSTATE
Clinical Trial Site85724TucsonArizona
Clinical Trial Site92708Fountain ValleyCalifornia
Clinical Trial Site92093La JollaCalifornia
Clinical Trial Site90027Los AngelesCalifornia
Clinical Trial Site90602WhittierCalifornia
Clinical Trial Site80045AuroraColorado
Clinical Trial Site80218DenverColorado
Clinical Trial Site80401GoldenColorado
Clinical Trial Site81505Grand JunctionColorado
Clinical Trial Site06810DanburyConnecticut

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