What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as Selective Estrogen Receptor Degraders (SERDs) like fulvestrant and aromatase inhibitors, often have side effects including hot flashes, joint pain, fatigue, and bone density loss. Tamoxifen, another endocrine therapy, can cause vasomotor symptoms, vaginal discharge or dryness, nausea, depression, and a slight increase in thromboembolic events. Rare but serious side effects include ocular toxicity, hepatotoxicity, and an increased risk of endometrial carcinoma.

What prior FDA approvals exist?

The FDA has approved several treatments for HR+/HER2- advanced breast cancer, including selective estrogen receptor degraders (SERDs) like fulvestrant. Fulvestrant is commonly used in patients whose disease has progressed following endocrine therapy. Additionally, aromatase inhibitors such as letrozole and anastrozole are frequently used in combination with CDK4/6 inhibitors like palbociclib. These therapies aim to inhibit estrogen receptor signaling, which is crucial for the growth of hormone receptor-positive breast cancer.

What other types of research exist?

Promising alternatives to Palazestrant (OP-1250) for breast cancer patients include: 1) Fulvestrant, another SERD, which has been used effectively in combination with other therapies like CDK4/6 inhibitors. 2) Anastrozole and other aromatase inhibitors, which have shown improved relapse-free survival in comparison to tamoxifen. 3) Newer SERMs like LY-353381, which are under investigation. 4) Combination therapies involving CDK4/6 inhibitors such as palbociclib with fulvestrant and goserelin, which have demonstrated significant progression-free survival improvement.

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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

No Placebo-Only Group

Pivotal Trial

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 below

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My cancer can be measured or is only in my bones.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My breast cancer is ER positive, HER2 negative, advanced, and cannot be cured with surgery or radiation.

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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:

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My cancer is causing symptoms or organ failure, making me ineligible for hormone therapy.

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I need urgent treatment for cancer spread to my brain or spinal cord.

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I have had chemotherapy for cancer that has spread.

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I have been treated with elacestrant or a trial drug for estrogen receptor-positive cancer.

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until death due to any cause (estimated as up to 4 years) for reporting.

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 more

Secondary study objectives

Trial: Overall Survival (OS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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)

0 / 9Eligibility criteria met

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.