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

What this study is about

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 join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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 this trial is running

• Clinical Trial Site, Tucson, Arizona, United States
• Clinical Trial Site, Fountain Valley, California, United States
• Clinical Trial Site, Glendale, California, United States
• Clinical Trial Site, La Jolla, California, United States
• Clinical Trial Site, Los Alamitos, California, United States
• Clinical Trial Site, Los Angeles, California, United States
• Clinical Trial Site, Whittier, California, United States
• Clinical Trial Site, Aurora, Colorado, United States
• Clinical Trial Site, Denver, Colorado, United States
• Clinical Trial Site, Golden, Colorado, United States
• Clinical Trial Site, Grand Junction, Colorado, United States
• Clinical Trial Site, Danbury, Connecticut, United States

+ 221 more sites.

Who to contact

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

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06016738.