Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Olema Pharmaceuticals, Inc. (Voir sur ClinicalTrials)
novembre 2023
septembre 2027
02 avril 2026
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.
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 | 05/06/2026 09:55:04 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Clinical Trial Site - 25030 - Besançon - Doubs - France | Contact (sur clinicalTrials) | ||||
| Clinical Trial Site - 34070 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Clinical Trial Site - 44805 - Nantes - Loire-Atlantique - France | Contact (sur clinicalTrials) | ||||
| Clinical Trial Site - 60200 - Compiègne - Oise - France | Contact (sur clinicalTrials) | ||||
| Clinical Trial Site - 63011 - Clermont-Ferrand - Puy-de-Dôme - France | Contact (sur clinicalTrials) | ||||
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 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 can be pre-, peri- or postmenopausal.
- Male and pre- or peri-menopausal female participants must be willing to take a GnRH
(or LHRH) agonist.
Key exclusion criteria:
- Symptomatic visceral disease, imminent organ failure, or any other reason that makes
the participant ineligible for endocrine monotherapy.
- Previously received chemotherapy in the advanced/metastatic setting.
- Previously received treatment with elacestrant or an investigational estrogen
receptor-directed therapy.
- History of allergic reactions to study treatment.
- Any contraindications to the selected standard-of-care endocrine therapy in the
local prescribing information.
- Symptomatic central nervous system metastases, carcinomatous meningitis,
leptomeningeal disease, or a spinal cord compression that require immediate
treatment.
- Clinically significant comorbidities such as significant cardiac or cerebrovascular
disease, gastrointestinal disorders that could affect absorption of study treatment.