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

Description

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.

Conditions

Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma

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Study Overview

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Study Details

Study 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.

A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Tucson

Clinical Trial Site, Tucson, Arizona, United States, 85724

Fountain Valley

Clinical Trial Site, Fountain Valley, California, United States, 92708

La Jolla

Clinical Trial Site, La Jolla, California, United States, 92093

Los Angeles

Clinical Trial Site, Los Angeles, California, United States, 90027

Whittier

Clinical Trial Site, Whittier, California, United States, 90602

Aurora

Clinical Trial Site, Aurora, Colorado, United States, 80045

Denver

Clinical Trial Site, Denver, Colorado, United States, 80218

Golden

Clinical Trial Site, Golden, Colorado, United States, 80401

Grand Junction

Clinical Trial Site, Grand Junction, Colorado, United States, 81505

Danbury

Clinical Trial Site, Danbury, Connecticut, United States, 06810

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Olema Pharmaceuticals, Inc.,

Medical Director, MD, STUDY_DIRECTOR, Olema Pharmaceuticals, Inc.

Study Record Dates

2027-09-30