A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)
Olema Pharmaceuticals, Inc.
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.
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). 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 inc…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugPalazestrant
Participants will be treated with palazestrant once daily on a 4 week (28 day) cycle. Doses evaluated in the dose-selection part will be 120 mg once daily and 90 mg once daily.
- DrugFulvestrant
Participants will be treated with fulvestrant on C1D1, C1D15, and then on Day 1 of every subsequent 4 week (28 day) cycle
- DrugAnastrozole
Participants will be treated with anastrozole once daily on a 4 week (28 day) cycle
- DrugLetrozole
Participants will be treated with letrozole once daily on a 4 week (28 day) cycle
- DrugExemestane
Participants will be treated with exemestane once daily on a 4 week (28 day) cycle
Locations (233)
- Clinical Trial SiteTucson, Arizona
- Clinical Trial SiteFountain Valley, California
- Clinical Trial SiteGlendale, California
- Clinical Trial SiteLa Jolla, California
- Clinical Trial SiteLos Alamitos, California
- Clinical Trial SiteLos Angeles, California