At a glance
ClinicalIndex Comparison Record- ✓Adult female or male participants
- ✓ER+, HER2- locally advanced or metastatic breast cancer not amenable to curative therapy
- ✓Evaluable disease (measurable or bone-only)
- ✓Prior CDK4/6 inhibitor with endocrine therapy in advanced setting, plus one additional ET monotherapy line allowed
- ✕Symptomatic visceral disease or imminent organ failure
- ✕Prior chemotherapy in advanced/metastatic setting
- ✕Prior treatment with elacestrant or investigational ER-directed therapy
- ✕History of allergic reactions to study treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Palazestrant, Fulvestrant, and 3 other interventions for Breast Cancer and 4 related conditions. Currently recruiting, targeting 510 participants across 233 sites in 26 countries.
Signals
Detailed 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.
Study Details
Timeline
Interventions
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.
Participants will be treated with fulvestrant on C1D1, C1D15, and then on Day 1 of every subsequent 4 week (28 day) cycle
Participants will be treated with anastrozole once daily on a 4 week (28 day) cycle
Participants will be treated with letrozole once daily on a 4 week (28 day) cycle
Participants will be treated with exemestane once daily on a 4 week (28 day) cycle