Status:
RECRUITING
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
Lead Sponsor:
Olema Pharmaceuticals, Inc.
Conditions:
Breast Cancer
Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 whos...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT06016738
Start Date
November 16 2023
End Date
September 30 2027
Last Update
March 13 2026
Active Locations (233)
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1
Clinical Trial Site
Tucson, Arizona, United States, 85719
2
Clinical Trial Site
Fountain Valley, California, United States, 92708
3
Clinical Trial Site
Glendale, California, United States, 91204
4
Clinical Trial Site
La Jolla, California, United States, 92093