Study Comparing OP-1250 (Palazestrant) with Standard Treatments for Advanced ER+/HER2- Breast Cancer

Sponsor: Olema Pharmaceuticals, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06016738

Provider View

This phase 3 clinical trial is testing a new drug, palazestrant (OP-1250), against standard treatments like fulvestrant or aromatase inhibitors in patients with advanced breast cancer that has progressed after previous hormone therapy and a CDK4/6 inhibitor.

Patient Parameters

Program Overview

This study is an international trial that aims to compare the safety and effectiveness of a new drug, palazestrant (OP-1250), with standard hormone therapies such as fulvestrant or aromatase inhibitors (anastrozole, letrozole, or exemestane) in treating advanced or metastatic ER+/HER2- breast cancer. The trial is open to adults whose cancer has worsened after one or two previous hormone treatments, including one combined with a CDK4/6 inhibitor. Initially, about 120 participants will be randomly assigned to receive one of two doses of palazestrant or standard hormone therapy. Later, around 390 participants will be assigned to either the selected dose of palazestrant or standard hormone therapy.

Description

This clinical trial is designed to test a new treatment, palazestrant (OP-1250), for advanced breast cancer that is ER+ and HER2-. The trial will compare this new drug to standard hormone therapies like fulvestrant or aromatase inhibitors. Participants will be adults with advanced breast cancer that has progressed after previous hormone treatments, including one with a CDK4/6 inhibitor. The study will start with a dose-selection phase involving about 120 participants, who will be randomly assigned to receive one of two doses of palazestrant or standard hormone therapy. After this phase, approximately 390 participants will be randomly assigned to receive either the chosen dose of palazestrant or standard hormone therapy. The trial aims to determine which treatment is safer and more effective.

Eligibility Criteria

Inclusion Criteria

  • Adult men and women with advanced or metastatic ER+, HER2- breast cancer that cannot be cured.
  • Cancer that can be measured or is present only in the bones.
  • Previously treated with a CDK4/6 inhibitor and hormone therapy for advanced cancer. One additional hormone therapy is allowed if it lasted at least 6 months.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Sufficient blood, liver, and kidney function.
  • Female participants can be at any stage of menopause.
  • Male and pre- or peri-menopausal female participants must agree to take a hormone therapy called a GnRH (or LHRH) agonist.

Exclusion Criteria

  • Severe symptoms from cancer affecting organs or any condition that makes hormone therapy unsuitable.
  • Previous chemotherapy for advanced or metastatic cancer.
  • Previous treatment with elacestrant or similar investigational drugs.
  • History of allergic reactions to the study drugs.
  • Any medical reasons that prevent the use of standard hormone therapies.
  • Cancer that has spread to the brain or spinal cord and requires immediate treatment.
  • Other serious health conditions, such as heart or blood vessel diseases, or digestive issues that could affect the study treatment.

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