Clinical Trial

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) OP-1250-302

MOA: Palazestrant (OP-1250) is an oral complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD)

Key Eligibility Criteria:

• Confirmed ER+ (≥1%) /HER2-negative MBC and one of the below:
  • de novo MBC (including recurrent BC in pts who didn’t receive adj ET)
  • Disease recurrence after 12 months of completing adj ET (± CDK4/6i)
• Patients with recurrence during adjuvant ET received for at least 24 months are excluded
• ≥1 measurable lesion per RECIST v1.1 or ≥1 lytic or lytic/blastic bone lesion evaluable by CT/MRI
• Prior tx with fulvestrant, elacestrant or any other investigational ET, in any setting, are excluded
• Currently/prior anti-cancer tx (ET, targeted tx, chemo, ADC) for ER+/HER2- MBC are excluded
• Known active/symptomatic CNS metastases, carcinomatous meningitis, leptomeningeal disease or spinal cord compression are excluded