OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
- Conditions
- Interventions
- Registration Number
- NCT06016738
- Lead Sponsor
- Olema Pharmaceuticals, Inc.
- 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 whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.
- 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 single agent to the standard of care endocrine therapy: either fulvestrant or an aromatase inhibitor (anastrozole, letrozole, or exemestane).
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Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 510
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Endocrine Therapy Letrozole Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane) Standard of Care Endocrine Therapy Anastrozole Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane) Standard of Care Endocrine Therapy Fulvestrant Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane) Palazestrant (OP-1250) Palazestrant Participants will receive Palazestrant Standard of Care Endocrine Therapy Exemestane Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
- Primary Outcome Measures
Name Time Method Dose-Selection Part: Incidence of dose reduction From Date of Randomization up to 16 weeks To evaluate the number of participants reducing the dose of palazestrant
Dose-Selection Part: Incidence of drug discontinuation From Date of Randomization up to 16 weeks To evaluate the number of participants discontinuing palazestrant
Trial: Progression-Free Survival (PFS) From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 2 years) To compare PFS, based on a Blinded Independent Review Committee (BIRC) assessment, between arms of OP-1250 and standard-of-care treatment. This will be assessed separately in populations of ESR1-mutation detected and ESR1-mutation not detected participants.
Dose-Selection Part: Incidence of adverse events From Date of Randomization up to 16 weeks To evaluate the number of participants with adverse events
- Secondary Outcome Measures
Name Time Method Trial: Overall Survival (OS) From Date of Randomization until Death Due to Any Cause (estimated as up to 4 years) To compare OS between arms of OP-1250 and standard-of-care treatment. This will be assessed separately in populations of ESR1 mutation detected and ESR1 mutation not detected participants.
Trial Locations
- Locations (2)
Clinical Trial Site
🇬🇧London, United Kingdom
Clinical Trials Site
🇲🇾Sungai Petani, Kedah, Malaysia