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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Palazestrant (drug), Fulvestrant (drug), Anastrozole (drug), Letrozole (drug)
How long the study runs: Study runs about 51 months (dates as stated)
About the drug or intervention: Palazestrant — drug: Participants will be treated with palazestrant once daily on a 4 week (28 day) cycle. · Fulvestrant — drug: Participants will be treated with fulvestrant on C1D1, C1D15, and then on Day 1 of every subsequent 4 week (28 day) cycle · Anastrozole — drug: Participants will be treated with anastrozole once daily on a 4 week (28 day) cycle · Letrozole — drug: Participants will be treated with letrozole once daily on a 4 week (28 day) cycle · Exemestane — drug: Participants will be treated with exemestane once daily on a 4 week (28 day) cycle
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 510
Started: 2023-11-16
Last checked: 2025-08

Plain English Summary

What is this study?

• Testing a new treatment for breast cancer
• Phase3 - 510 participants
• 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

Who can take part?

• Ages 18 Years and over
• Diagnosed with breast cancer

Where?

• Leicester - Clinical Trial Site
• Nottingham - Clinical Trial Site
• Taunton - Clinical Trial Site
• Bodelwyddan - Clinical Trial Site
• +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This is an international, multicenter, randomized, open-label, active-controlled, phase 3 clinical trial. The purpose of this trial is to compare the safety and efficacy of palazestrant (OP-1250) as a single agent to the standard of care endocrine therapy: either fulvestrant or an aromatase inhibitor (anastrozole, letrozole, or exemestane). This trial is seeking adult participants with ER+, HER2- advanced or metastatic breast cancer whose disease has relapsed or progressed on 1 or 2 prior lines of standard-of-care endocrine therapy for metastatic breast cancer. Prior lines of therapy must include one line of endocrine therapy in combination with a CDK 4/6 inhibitor. In the dose-selection part of the trial, approximately 120 participants will be randomized to one of the two doses of palazestrant or to the standard-of-care endocrine therapy. Thereafter, approximately 390 participants will be randomized to palazestrant at the selected dose or to the standard-of-care endocrine therapy.

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

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

Biomarkers mentioned

ERHER2

What the study is looking for

✓Adult female or male participants.
✓ER+, HER2- that has grown locally or that has spread breast cancer that is not amenable to curative therapy.
✓Evaluable disease (cancer that can be measured on scans or bone-only disease).
✓activity scale (ECOG) performance status of 0 or 1.
✓Adequate blood, liver, and kidney functions.

Who cannot take part

✗causing symptoms visceral disease, imminent organ failure, or any other reason that makes the participant ineligible for...
✗Previously received drug treatment in the advanced/that has spread 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.

See the full criteria

Key inclusion 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. Key exclusion criteria: * 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.

Where Is This Study? (5 UK sites)

Clinical Trial Site

Leicester LE1 5WW, United Kingdom

Clinical Trial Site

Nottingham NG5 1PB, United Kingdom

Clinical Trial Site

Taunton TA1 5DA, United Kingdom

Clinical Trial Site

Bodelwyddan LL18 5UJ, United Kingdom

Clinical Trial Site

London EC1A 7BE, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2025-08