RECRUITING

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

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Conditions

Breast CancerAdvanced Breast CancerMetastatic Breast CancerER Positive Breast CancerHER2 Negative Breast Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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)

Quick Facts

Study Start:2023-11-16
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06016738

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult female or male participants.
  2. * ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
  3. * Evaluable disease (measurable disease or bone-only disease).
  4. * 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.
  5. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. * Adequate hematologic, hepatic, and renal functions.
  7. * Female participants can be pre-, peri- or postmenopausal.
  8. * Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.
  1. * Symptomatic visceral disease, imminent organ failure, or any other reason that makes the participant ineligible for endocrine monotherapy.
  2. * Previously received chemotherapy in the advanced/metastatic setting.
  3. * Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy.
  4. * History of allergic reactions to study treatment.
  5. * Any contraindications to the selected standard-of-care endocrine therapy in the local prescribing information.
  6. * Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
  7. * Clinically significant comorbidities such as significant cardiac or cerebrovascular disease, gastrointestinal disorders that could affect absorption of study treatment.

Contacts and Locations

Study Contact

Olema Pharmaceuticals, Inc.
CONTACT
415-651-7206
OPERA-01@olema.com

Principal Investigator

Medical Director, MD
STUDY_DIRECTOR
Olema Pharmaceuticals, Inc.

Study Locations (Sites)

Clinical Trial Site
Tucson, Arizona, 85724
United States
Clinical Trial Site
Fountain Valley, California, 92708
United States
Clinical Trial Site
La Jolla, California, 92093
United States
Clinical Trial Site
Los Angeles, California, 90027
United States
Clinical Trial Site
Whittier, California, 90602
United States
Clinical Trial Site
Aurora, Colorado, 80045
United States
Clinical Trial Site
Denver, Colorado, 80218
United States
Clinical Trial Site
Golden, Colorado, 80401
United States
Clinical Trial Site
Grand Junction, Colorado, 81505
United States
Clinical Trial Site
Danbury, Connecticut, 06810
United States
Clinical Trial Site
Newark, Delaware, 19713
United States
Clinical Trials Site
Jacksonville, Florida, 32223
United States
Clinical Trial Site
Margate, Florida, 33063
United States
Clinical Trial Site
Orlando, Florida, 32804
United States
Clinical Trial Site
Plantation, Florida, 33324
United States
Clinical Trial Site
Tamarac, Florida, 33321
United States
Clinical Trial Site
Atlanta, Georgia, 30322
United States
Clinical Trial Site
Chicago, Illinois, 60616-2315
United States
Clinical Trial Site
Chicago, Illinois, 60637
United States
Clinical Trial Site
Urbana, Illinois, 61801
United States
Clinical Trial Site
Baton Rouge, Louisiana, 70809
United States
Clinical Trial Site
Baltimore, Maryland, 21201
United States
Clinical Trial Site
Boston, Massachusetts, 02111
United States
Clinical Trial Site
St Louis Park, Minnesota, 55426
United States
Clinical Trial Site
Lincoln, Nebraska, 68510-2496
United States
Clinical Trial Site
Farmington, New Mexico, 87401
United States
Clinical Trial Site
New York, New York, 10032
United States
Clinical Trial Site
Port Jefferson Station, New York, 11776
United States
Clinical Trial Site
Dayton, Ohio, 45409
United States
Clinical Trial Site
Toledo, Ohio, 43623
United States
Clinical Trial Site
Portland, Oregon, 97239
United States
Clinical Trial Site
Nashville, Tennessee, 37203
United States
Clinical Trial Site
Nashville, Tennessee, 37208
United States
Clinical Trial Site
Dallas, Texas, 75246
United States
Clinical Trial Site
Dallas, Texas, 75390
United States
Clinical Trial Site
Houston, Texas, 77030
United States
Clinical Trial Site
Spokane, Washington, 99204
United States
Clinical Trial Site
Spokane, Washington, 99218
United States

Collaborators and Investigators

Sponsor: Olema Pharmaceuticals, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-16
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2023-11-16
Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

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