Clinical trial · Interventional
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)
NCT07085767CI-TRIAL-00122210OPERA-02recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| ER Positive Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
| HER2 Negative Breast Carcinoma | HER2-Negative Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Locally Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
| Letrozole-matching placebo | Drug | — | UNRESOLVED |
| Palazestrant | Drug | — | UNRESOLVED |
| Palazestrant matching-placebo | Drug | — | UNRESOLVED |
| Ribociclib | Drug | Ribociclib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Palazestrant
- description
- Participants will receive palazestrant, ribociclib and letrozole-matching placebo
- interventionNames
- Drug: Palazestrant
- Drug: Letrozole-matching placebo
- Drug: Ribociclib
- type
- ACTIVE_COMPARATOR
- label
- Letrozole
- description
- Participants will receive letrozole, ribociclib and palazestrant-matching placebo
- interventionNames
- Drug: Ribociclib
- Drug: Letrozole
- Drug: Palazestrant matching-placebo
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 per RECIST 1.1 or bone-only disease). * De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors) * 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 Criteria: * Disease recurrence during adjuvant endocrine therapy * Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer. * Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting. * History of allergic reactions to study treatment. * Any contraindications to letrozole and ribociclib. * Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.