Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Olema Pharmaceuticals, Inc. (Voir sur ClinicalTrials)
novembre 2025
janvier 2032
19 juillet 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Barbara PISTILLI | 22/07/2026 18:00:06 | Contacter | ||
Critères
Tous
- 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.