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Hormone Therapy
OP-1250 for Advanced Breast Cancer (OPERA-01 Trial)
Phase 3
Recruiting
Research Sponsored by Olema Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evaluable disease (measurable disease or bone-only disease)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must not have
Symptomatic visceral disease, imminent organ failure, or any disease burden that makes the participant ineligible for endocrine therapy
Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until death due to any cause (estimated as up to 4 years)
Awards & highlights
Summary
This trial is testing a new drug called palazestrant to see if it works better than current treatments for adults with advanced breast cancer that has not responded to previous therapies. The drug aims to stop cancer growth by blocking estrogen.
Who is the study for?
This trial is for adults with ER+/HER2- advanced breast cancer that's progressed after endocrine therapy and a CDK4/6 inhibitor. Participants need to be in good physical condition (ECOG 0 or 1), have proper organ function, and if male or pre-menopausal female, agree to take hormone-blocking injections.
What is being tested?
The study compares OP-1250, a new treatment option, against standard treatments like fulvestrant or aromatase inhibitors (Anastrozole, Letrozole, Exemestane) in patients whose breast cancer has worsened despite previous therapies.
What are the potential side effects?
Potential side effects may include reactions related to hormone changes due to the treatments such as hot flashes and mood swings. There could also be injection site reactions from GnRH agonists for some participants.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured or is only in my bones.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My breast cancer is ER positive, HER2 negative, advanced, and cannot be cured with surgery or radiation.
Select...
I am willing to take hormone therapy if I am a man or a woman who has not gone through menopause.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer is causing symptoms or organ failure, making me ineligible for hormone therapy.
Select...
I need urgent treatment for cancer spread to my brain or spinal cord.
Select...
I have had chemotherapy for cancer that has spread.
Select...
I have been treated with elacestrant or a trial drug for estrogen receptor-positive cancer.
Select...
I have no health issues preventing me from taking standard hormone therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until death due to any cause (estimated as up to 4 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until death due to any cause (estimated as up to 4 years)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose-Selection Part: Incidence of adverse events
Dose-Selection Part: Incidence of dose reduction
Dose-Selection Part: Incidence of drug discontinuation
+1 moreSecondary study objectives
Trial: Overall Survival (OS)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Palazestrant (OP-1250)Experimental Treatment1 Intervention
Participants will receive Palazestrant
Group II: Standard of Care Endocrine TherapyActive Control4 Interventions
Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Breast cancer treatments often target hormone receptors, particularly in hormone receptor-positive, HER2-negative cases. Common treatments include Selective Estrogen Receptor Modulators (SERMs) like tamoxifen, which block estrogen receptors, and aromatase inhibitors like letrozole, which reduce estrogen production.
Selective Estrogen Receptor Degraders (SERDs) like fulvestrant and the investigational drug Palazestrant (OP-1250) work by degrading estrogen receptors, thereby inhibiting estrogen-driven cancer growth. These mechanisms are crucial as they directly interfere with the hormonal pathways that many breast cancers rely on for growth and survival, offering targeted and effective treatment options for patients.
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Who is running the clinical trial?
Olema Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
368 Total Patients Enrolled
2 Trials studying Breast Cancer
215 Patients Enrolled for Breast Cancer
Medical Director, MDStudy DirectorOlema Pharmaceuticals, Inc.
80 Previous Clinical Trials
16,006 Total Patients Enrolled
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